Coverage Policy Manual
Policy #: 2013005
Category: Surgery
Initiated: January 2013
Last Review: December 2023
  Treatment of Sacroiliac Joint (SIJ) Pain
Description:
Sacroiliac joint (SIJ) arthrography using fluoroscopic guidance with an injection of an anesthetic has been explored as a diagnostic test for SIJ pain. Duplication of the patient’s pain pattern with the injection of contrast medium suggests a sacroiliac etiology, as does relief of chronic back pain with an injection of local anesthetic. Treatment of SIJ pain with corticosteroids, radiofrequency ablation (RFA), stabilization, or minimally invasive SIJ fusion has also been explored.
 
Similar to other structures in the spine, it is assumed the sacroiliac joint (SIJ) may be a source of low back pain. In fact, before 1928, the SIJ was thought to be the most common cause of sciatica. In 1928, the role of the intervertebral disc was elucidated, and from that point forward, the SIJ received less research attention.
 
Research into SIJ pain has been plagued by a lack of a criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, SIJ pain typically presents without any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for SIJ pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the patient. Further confounding the study of the SIJ is that multiple structures, (e.g., posterior facet joints, lumbar discs) may refer pain to the area surrounding the SIJ.
 
Because of inconsistent information obtained from history and physical examination, some have proposed the use of image-guided anesthetic injection into the SIJ for the diagnosis of SIJ pain. Treatments being investigated for SIJ pain include prolotherapy, corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis. Some procedures have been referred to as SIJ fusion but may be more appropriately called fixation due to little to no bridging bone on radiographs. Devices for SIJ fixation/fusion that promote bone ingrowth to fixate the implants include a triangular implant (iFuse Implant System) and cylindrical threaded devices (e.g., Rialto, SImmetry, Silex, SambaScrew, SI-LOK). Some devices also have a slot in the middle where autologous or allogeneic bone can be inserted. This added bone is intended to promote the fusion of the SIJ
 
A 2021 review identified 33 different devices that could be implanted using either a lateral transiliac approach (n=21), posterior allograft approach (n=6), posterolateral approach (n=3), or a combination of the approaches (n=3) (Himstead et al, 2021). The iliosacral and posterolateral approaches use up to 3 implants that pass through the ilium, while the posterior approach involves inserting implants directly into the SIJ. Many of the devices are intended to be used with allograft bone. Implants composed entirely of allograft bone are typically inserted through a posterior approach. The authors found no published evidence for 23 of the 33 devices identified.
 
Regulatory Status
A number of percutaneous or minimally invasive fixation/fusion devices have been cleared for marketing by the FDA through the 510(k) process. FDA product codes: OUR.
 
Bone allograft products that are regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for homologous use may be marketed specifically for use in SIJ fusion.
 
Below is a list of select Sacroiliac Fusion Devices (Listed by Device, Manufacturer, Features, FDA Clearance, Clearance Date)
 
Lateral Transiliac Approach
Titanium Triangular Implants
    • iFuse® SI Bone Titanium triangular rod with conventional manufacturing K110838 2011
    • iFuse® 3D SI Bone Titanium triangular 3D printed porous rod K162733 2017
 
3D Printed Cannulated Screw
    • iFuse TORQ® Implant System SI Bone 3D Printed Cannulated Screw K222605 2022
    • T-FIX® 3DSI Joint Fusion System Cutting Edge Spine, LLC 3D Printed Cannulated Screw K214123 2023
 
Cannulated Screws
    • FIREBIRD SI Fusion System™ Orthofix Cannulated screw K200696 2020
    • SambaScrew® Orthofix Cannulated screw K121148 2012
    • Silex Sacroiliac Joint Fusion® X-Spine Systems Cannulated screw K140079 2014
    • SI-LOK® Sacroiliac Joint Fixation System Globus Medical Cannulated screw K112028 2011
    • SImmetry® Sacroiliac Joint Fusion System RTI Cannulated screw K102907 2010
    • SIimpact® Sacroiliac Joint Fixation System Life Spine Cannulated screw K180749 2018
    • SIros™ Genesys Spine Cannulated screw K191748 2019
    • UNITY Sacroiliac Joint Fixations System Dio Medical Corp. Cannulated screw K222448 2022
    • Integrity-SI® Fusion System OsteoCentric Technologies Cannulated screw K230226 2023
    • Sacrix® Sacroiliac Joint Fusion Device System LESspine Innovations Cannulated screw K232605 2023
 
3D printed screw with porus graft windows
    • Triton SI Joint Fixation System™ Choice Spine 3D printed screw with porous graft windows K211449 2021
 
Metallic Fastener
    • PathLoc SI Joint Fusion System L & K Biomed Co., Ltd. Metallic fastener K231841 2023
    • SI-Cure Sacroiliac Joint Fusion System Alevio, LLC Metallic fastener K231951 2023
 
Posterolateral Approach
Cannulated Screw
    • Rialto™ SI Joint Fusion System Medtronic Cannulated screw K161210 2016
 
Solid or hollow-cored screw
    • SacroFuse®/ SIJFuse™ SpineFrontier Solid or hollow-cored screw K150017 2015
    • SILO TFX MIS Sacroiliac Joint Fixation System Aurora Spine, Inc Solid or hollow-cored screw K221047 2022
 
Posterior Approach
Metal Plug
    • Catamaran™ Tenon Medical Metal plug K180818 2018
    • NADIA™ SI Fusion System (DIANA) Ilion Medical Metal plug K190580 2020
    • CATAMARAN SI Joint Fusion System Tenon Medical, Inc. Metal plug K231944 2023
    • TiLink-P SI Joint Fusion System Surgentec, LLC Metal plug K230857 2023
 
Bone Allograft
    • CornerLoc™ Fusion Foundation Solutions Bone allograft HCT/P
    • LinQ™ SI Joint Stabilization PainTEQ Bone allograft HCT/P
    • PsiF™ Posterior Sacroiliac Fusion Omnia Medical Bone allograft HCT/P
    • SIFix System® NuTech Bone allograft HCT/P
    • TransFasten™ Captiva Spine Bone allograft HCT/P
 
Cannulated Screw
    • Invictus® Spinal Fixation System Alphatec Spine, Inc. Cannulated screw K232275 2023
 
Coding
Effective in 2015, there is a CPT category I code for percutaneous or minimally invasive stabilization:
 
27279: Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device.
 
Effective Prior to 2015
Effective July 1, 2013, there is a CPT category III code for percutaneous or minimally invasive stabilization:
 
0334T: Sacroiliac joint stabilization for arthrodesis, percutaneous or minimally invasive (indirect visualization), includes obtaining and applying autograft or allograft (structural or morselized), when performed, includes image guidance when performed (e.g., CT or fluoroscopic).
Policy/
Coverage:
This policy does not address the treatment of sacroiliac joint (SIJ) pain due to infection, trauma or neoplasm.
 
Effective July 2023
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
A. A diagnosis of sacroiliac joint pain meets primary coverage criteria when ALL the following requirements exist:
    1. Moderate to severe low back pain primarily experienced over the anatomical location of the SI joints between the upper level of the iliac crests and the gluteal fold, AND
    2. Low back pain duration of at least three (3) months, AND
    3. Low back pain below L5 without radiculopathy, AND
    4. Clinical findings and/or imaging studies do not suggest any other diagnosed or obvious cause of the lumbosacral pain (such as central spinal stenosis with neurogenic claudication/myelopathy, foraminal stenosis or disc herniation with concordant radicular pain/radiculopathy, infection, tumor, fracture, pseudoarthrosis, or pain related to spinal instrumentation), AND
    5. At least three positive findings from the below provocative maneuvers: FABER, Gaenslen, Thigh Thrust or Posterior Shear, SI Compression, SI Distraction and/or Yeoman Tests, AND
B. Diagnostic Sacroiliac Joint Injections
Diagnostic sacroiliac joint injections meet primary coverage criteria  for an individual when ALL the following criteria exist:
    1. The individual meets ALL of the above criteria (in section A) for sacroiliac joint pain, AND
    2. Low back pain persists despite a minimum of 3 months of conservative therapies which consists of:
        1. Use of prescription-strength analgesics for several weeks at a dose sufficient to induce a therapeutic response (analgesics should include anti-inflammatory medications with or without adjunctive medications such as nerve membrane stabilizers or muscle relaxants); AND
        2. Participation in at least 6 weeks of physical therapy (including active exercise) or documentation of why the individual could not tolerate physical therapy; AND
        3. Evaluation and appropriate management of associated cognitive, behavioral, or addiction issues; AND
        4. Documentation of individual compliance with the preceding criteria.
             AND
3. The SI joint injections must be performed under CT or fluoroscopy image guidance with contrast, (ultrasound guidance may be allowed when there is a documented contrast allergy or pregnancy, since the accuracy with ultrasound guidance is inferior to fluoroscopic guidance, AND
4. SI joint injection are not performed with other musculoskeletal injections in the lumbosacral spine, AND
5. The documentation should show direct causal benefit from the SI joint injection and not from other musculoskeletal injections or treatments, AND
6. The diagnostic SIJ injection provided a minimum of 75% relief of primary (index) pain with the diagnostic SIJ injection (a positive diagnostic response is defined as ≥75% sustained and constant pain relief for the duration of the local anesthetic and corticosteroid and ≥75% sustained and constant pain relief) as measured by use of the same pain scale at baseline. The measurements of pain must be taken pre-injection on the day of the SIJ injection, post-intervention on the day of the injection, and the days following the injection to substantiate and corroborate the pain scores consistent with the pain relief for the duration of the local anesthetic and corticosteroid.
 
Limitation: No more than two (2) diagnostic joint sessions, unilateral or bilateral. To clarify, two unilateral sessions, if performed on one side at one session and on the opposite side at a different session, would meet the limitation of two (2) diagnostic sessions.
 
C. Therapeutic Sacroiliac Joint Injections:
Therapeutic sacroiliac joint injections (SIJI) meet primary coverage criteria for individuals who meet ALL the following requirements:
    1. The individual meets all of the above criteria for a diagnosis of sacroiliac joint pain (section A) and meets all of the above criteria for diagnostic sacroiliac joint injections (section B), AND
    2. Subsequent therapeutic SIJI are considered medically reasonable and necessary when the subsequent SIJI are provided at the same anatomic site as therapeutic SIJI; AND
    3. The therapeutic SIJI produced at least consistent 50% pain relief or at least 50% consistent improvement in the ability to perform previously painful movements and activities of daily living (ADLs) for at least three (3) months from the proximate therapeutic SIJI procedure and compared to baseline measurements for ADLS and painful movements or pain relief using the same pain scale AND
    4. The SI joint injections must be performed under CT or fluoroscopy image guidance with contrast (ultrasound guidance may be allowed when there is a documented contrast allergy or pregnancy, since the accuracy with ultrasound guidance is inferior to fluoroscopic guidance); AND
    5. SIJI is allowed no more frequently than every 3 months
 
Limitations: No more than four (4) therapeutic SIJI sessions, unilateral or bilateral, will be reimbursed per rolling 12 months. To clarify, a therapeutic SIJI session if performed on one side first and then on the opposite side at a different session would qualify as two (2) sessions for the limitation of four (4) therapeutic SIJ sessions
 
 
D.  Minimally invasive fixation/fusion of the SIJ using transiliac placement of a titanium triangular implant meets member benefit certificate primary coverage criteria of effectiveness when ALL of the following criteria are met:
 
 
    1. The individual meets all of the above criteria for a diagnosis of sacroiliac joint pain (section A) and meets all of the above criteria for diagnostic sacroiliac joint injections (section B), AND  
    2. Persistent pain for a duration of 6 months* or more that that impacts quality of life or limits activities of daily living as documented by BOTH of the following:
          1. Pain is at least 5 on a 0 to 10 rating scale (eg. VAS); AND
          2. Oswestry Disability Index (ODI) of 30 or more;
             AND
3. Failure of a minimum 6 months* of conservative nonsurgical treatment that must include ALL of the following:
        1. Medication optimization (prescription strength analgesics that includes at least one anti-inflammatory medication for several weeks at a dose sufficient to induce a therapeutic response)
        2. Activity modification
        3. Sacroiliac support belt
        4. Compliance with physical therapy for at least 6 weeks targeting lumbar spine, pelvis, sacroiliac joint, and hip, including a home exercise program OR documentation of why the patient could not tolerate physical therapy.
 
*Note:  The 6 months requirement of persistent pain and 6 months requirement of conservative nonsurgical treatment may overlap.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Injection of anesthetic for diagnosing SIJ pain not meeting the criteria outlined above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, injection of anesthetic for diagnosing SIJ pain not meeting the criteria outlined above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Injection of corticosteroid for SIJ pain not meeting the criteria outlined above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, injection of corticosteroid for SIJ pain not meeting the criteria outlined above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Arthrography of the SIJ does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, arthrography of the SIJ is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Minimally invasive sacroiliac joint fusion does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes with any device not listed above and under any condition not listed above, including but not limited to the presence of:
 
    1. Neoplasm or infection near the affected area
    2. Inflammatory arthropathy, ankylosing spondylitis or rheumatoid arthritis
    3. Acute trauma or fracture near the affected area
    4. Neural compression on imaging that correlates with symptoms
    5. Presence of generalized pain behavior (e.g., somotoform disorder) or generalized pain disorders (e.g., fibromyalgia)   
 
For members with contracts without primary coverage criteria, minimally invasive sacroiliac joint fusion is considered investigational with any device not listed above and under any condition not listed above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective March 01, 2022 through June 2023
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
Minimally invasive fixation/fusion of the SIJ using transiliac placement of a titanium triangular implant meets primary coverage criteria when ALL of the following criteria are met:
 
    • Persistent pain for a duration of 6 months* or more that that impacts quality of life or limits activities of daily living as documented by BOTH of the following:
        • Pain is at least 5 on a 0 to 10 rating scale (eg. VAS)
        • Oswestry Disability Index (ODI) of 30 or more; AND
 
    • Failure of a minimum 6 months* of conservative nonsurgical treatment that must include ALL of the following:
        • Medication optimization (prescription strength analgesics that includes at least one anti-inflammatory medication for several weeks at a dose sufficient to induce a therapeutic response)
        • Activity modification
        • Sacroiliac support belt
        • Compliance with physical therapy for at least 6 weeks targeting lumbar spine, pelvis, sacroiliac joint, and hip, including a home exercise program OR documentation of why the patient could not tolerate physical therapy; AND
 
    • Confirmation of the SI joint as a pain generator as demonstrated by ALL of the following:
        • Pain consistent with SI joint pain (typically pain caudal to L5 vertebra, localized over posterior SI joint)
        • A thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin’s point) in the absence of tenderness of similar severity elsewhere in the pelvic region (e.g., greater trochanter, lumbar spine, coccyx); and
        • There is an absence of generalized pain behavior (eg, somatoform disorder) or generalized pain disorders (eg, fibromyalgia);
        • There is a positive response to a cluster of THREE (3) provocative tests (eg, thigh thrust test, compression test, Gaenslen sign, distraction test, Patrick test, posterior provocation test); AND
 
    • Diagnostic imaging studies include ALL of the following:  
        • Imaging (plain radiographs and a CT or MRI) of the SI joint that excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy; and  
        • Imaging of pelvis (AP plain radiograph) to rule out concomitant hip pathology
        • Imaging of lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition (ankylosing spondylitis or rheumatoid arthritis) that can be causing low back or buttock pain; and
        • Imaging of SIJ indicates evidence of injury and/or degeneration; AND
 
    • There is at least a 75% reduction in pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular sacroiliac joint injection on 2 separate occasions  
 
*Note:  The 6 months requirement of persistent pain and 6 months requirement of conservative nonsurgical treatment may overlap.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Minimally invasive sacroiliac joint fusion does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes with any device not listed above and under any condition not listed above, including but not limited to the presence of:
 
    • Neoplasm or infection near the affected area
    • Inflammatory arthropathy, ankylosing spondylitis or rheumatoid arthritis
    • Acute trauma or fracture near the affected area
    • Neural compression on imaging that correlates with symptoms
    • Presence of generalized pain behavior (e.g., somotoform disorder) or generalized pain disorders (e.g., fibromyalgia)  
 
For members with contracts without primary coverage criteria, minimally invasive sacroiliac joint fusion is considered investigational with any device not listed above and under any condition not listed above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
Effective Prior to March 01, 2022
 
Minimally invasive sacroiliac joint fusion using the iFuse Implant System® or other devices does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, minimally invasive sacroiliac joint fusion using the iFuse Implant System® or other devices is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Rationale:
Literature Review
A literature search was conducted using the MEDLINE database and the clinicaltrials.gov website. The literature involving the study of the iFuse Implant System consists of small retrospective case series. The following is a summary of the identified literature.
 
Wise  and colleagues published results of a prospective study enrolling thirteen patients with sacroiliac pain (Wise, 2008). All thirteen patients underwent minimally invasive sacroiliac arthrodesis.  Six patients had bilateral fusions for a total of 19 joints fused. A 6 month CT scan showed an overall fusion rate of 89%. Low back pain, leg pain and dyspareunia scores on a visual analog scale (0-10) improved an average of 4.9, 2.4 and 2,6, respectively.
 
In 2012, Sachs and Capobianco reported results of a consecutive case series study of 11 patients treated with the iFuse Implant System® by a single surgeon (Sachs, 2012). Average pain scores decreased from 7.9 at baseline to 2.3 at the 12 month follow-up resulting in a statistically significant (p=0.000) improvement. Both authors were noted to have an affiliation with SI-Bone Inc.
 
The largest study identified was a retrospective study of 50 consecutive patients treated by a single surgeon with minimally invasive sacroiliac joint fusion (Rudolf, 2012). Medical records were reviewed for peri-operative characteristics, complications, pain, quality of life measures and satisfaction with surgery. All patients were contacted at 24 months post surgery to assess pain, satisfaction with surgery and work status. Ten peri-operative complications were reported including three patients with subcuticular skin closures that developed cellulitis and two patients had implant penetration into the sacral neural foramen. A non-displaced fracture was reported in one patient at the edge of the ilium adjacent to the sciatic notch.  The fracture was reported to have healed without intervention.
 
Ongoing Clinical Trials
This device is currently being studied in the following clinical trials:
 
NCT01640353- Sacroiliac Joint Fusion with iFuse Implant System (SIFI). This study is a phase 4 observational study to assess the use of the iFuse Implant System to treat degenerative sacroiliitis and sacroiliac disruption. The estimated completion date is September 2014.
 
NCT01681004-Investigation of Sacroiliac Fusion Treatment (INSITE). A Phase 4 study to compare outcomes in patients undergoing joint fusion using the iFuse Implant System® versus specific, targeted non-surgical treatment. The study is currently recruiting patients and has an estimated completion date of November 2014.
 
NCT 01741025-iFuse Implant System Minimally Invasive Arthrodesis (iMIA).  This study is a multicenter, randomized controlled trial comparing the safety and efficacy of the iFuse for patients with chronic disabling sacroiliac joint pain. This study is scheduled to begin enrollment in March 2013.
 
Regulatory Status
SI-Bone, Inc. originally received FDA 510K marketing clearance for the iFuse system in November 2008 for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac join disruptions and sacroiliitis. In March 2011, the FDA removed “fracture” from the intended use and gave marketing clearance for the iFuse system for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis (FDA, 2011).
 
 
2014 Update
A literature conducted through June 2014 using the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement.
 
A multicenter retrospective comparison of open versus minimally invasive sacroiliac joint fusion in 263 patients was identified (Smith, 2013). Because all patients received fusion, this trial does not offer evidence on the comparative effectiveness of sacroiliac fusion versus alternative treatment approaches. This study had a pragmatic design that included 7 participating sites; 3 surgeons had performed open sacroiliac joint surgery (n=149), and 4 had performed minimally invasive fusion with the iFuse Implant system (n=114). Patients who underwent minimally invasive fusion were an average of 10 years older and were more likely to have had prior lumbar fusion (47.4% vs 23.5%). Perioperatively, they had lower estimated blood loss (33 vs 288 mL), operating time (70 vs 163 min), and length of hospitalization (1.3 vs 5.1 days). At 12 months postsurgery, and after matching for age, gender, and history of prior lumbar fusion, pain scores were an average of 3 (of 10) points lower in the minimally invasive group (95% confidence interval, 2.1 to 4.0; p<0.001). Implant repositioning was performed in 3.5% of patients in the minimally invasive group, while 44% of patients in the open surgical group underwent removal of spinal implants for pain. (Note: A 2012 survey by the International Society for the Advancement of Spinal Surgery found that nearly 90% of surgeons who replied to the survey used a minimally invasive technique to perform sacroiliac joint fusion (International Society for the Advancement of Spinal Surgery, 2013).
 
In 2012, Rudolf reported a retrospective analysis of his first 50 consecutive patients treated with the iFuse Implant System (Rudolf, 2012). There were 10 perioperative complications, including implant penetration into the sacral neural foramen (2 patients) and compression of the L5 nerve (1 patient); these resolved with surgical retraction of the implant. At a minimum of 24 months’ follow-up (mean, 40 months), the treating surgeon was able to contact 45 patients. The mean pain score was 2, and 82% of patients had attained the minimum clinically important difference (MCID, defined as ≥2 of 10).
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The literature on arthrodesis (open or minimally invasive) for sacroiliac joint pain includes 1 RCT on minimally invasive fusion, 1 cohort study comparing open and minimally invasive sacroiliac fusion, and a number of case series.
 
In 2015, Whang and colleagues reported an industry-sponsored non-blinded RCT (NCT01681004) of the iFuse Implant System in 148 patients (Whang, 2015). Inclusion in the study was based on the determination of the sacroiliac joint as a pain generator from a combination of a history of sacroiliac joint-localized pain, positive provocative testing on at least 3 of 5 established physical tests, and at least a 50% decrease in sacroiliac point pain after image-guided local anesthetic injection into the joint. The duration of pain prior to enrollment averaged 6.4 years (range, 0.47 to 40.7 years). Prior treatments in the control group included physical therapy (78.3% of subjects), intra-articular steroid injections (91.3%), and RFA of the sacroiliac nerve roots (8.7%).
 
Patients were assigned in a 2:1 ratio to minimally invasive sacroiliac joint fusion (n=102) or to nonsurgical management (n=46). Non-surgical management included a step-wise progression, depending on individual patient needs, of pain medications, physical therapy (98% of patients), intra-articular steroid injections (73.9%), and RFA of sacral nerve roots (45.7%). The primary outcome measure was 6-month success rates, defined as the proportion of treated subjects with a 20-mm improvement in sacroiliac joint pain in the absence of severe device-related or neurologic adverse events or surgical revision. Missing values were considered to be treatment failures, and the study was considered to meet its endpoint if there was a posterior probability for superiority of fusion of at least 0.975 by Bayesian analysis. Patients in the control arm could cross-over to surgery after 6 months. Baseline scores indicated that the patients were severely disabled, with VAS pain scores averaging 82.3 out of 100 and Oswestry Disability Index (ODI) scores averaging 61.9.
 
At 6 months, success rates were 23.9% in the control group versus 81.4% in the surgical group (posterior probability of superiority > 0.999). A clinically important (≥15 point) improvement in the ODI was found in 27.3% of controls compared with 75.0% of fusion patients. Measures of quality of life (SF-36, EQ-5D) also improved to a greater extent in the surgery group. Opioid use remained high in both groups (70.5% for non-surgical controls and 58.0% for fusion patients (p=0.082). Although these results are generally positive, there is a high potential for bias in this nonblinded study with subjective outcome measures. Aside from non-blinding, the study was of high methodologic quality. Follow-up of all patients will continue through 24 months.
 
The International Society for the Advancement of Spine Surgery (ISASS) published a policy statement on minimally invasive sacroiliac joint fusion in 2014.34 ISASS states that patients who meet all of the following criteria may be eligible for minimally invasive sacroiliac joint fusion: significant sacroiliac joint pain or significant limitations in activities of daily living; pain confirmed on physical provocative examination maneuvers that stress the joint; confirmation of the sacroiliac joint as a pain generator with at least 75% acute decrease in pain immediately following fluoroscopically guided diagnostic joint block using local anesthetic; failure to respond to at least 6 months of non-surgical treatment; and additional or alternative diagnoses have been clearly considered, investigated and ruled out.
 
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Randomized Controlled Trials
In 2015, Whang and colleagues reported an industry-sponsored non-blinded RCT of the iFuse Implant System in 148 patients (Whang, 2015). Twelve-month follow-up to this RCT was reported by Polly and colleagues (Polly, 2015). However, by 12 months, almost all patients in the control group had crossed over to SIJ fusion. Two-year follow-up of this trial was reported by Polly and colleagues (Polly, 2016).  This last publication will be discussed in the case series section of this report. Trial inclusion was based on a determination of the SIJ as a pain generator from a combination of a history of SIJ-localized pain, positive provocative testing on at least 3 of 5 established physical tests, and at least a 50% decrease in SIJ pain after image-guided local anesthetic injection into the SIJ. The duration of pain before enrollment averaged 6.4 years (range, 0.47-40.7 years). A large proportion of subjects (37%) had previously undergone lumbar fusion, steroid SIJ infections (86%), and RFA (16%).
 
Patients were assigned 2:1 to minimally invasive SIJ fusion (n=102) or to nonsurgical management (n=46). Nonsurgical management included a stepwise progression of nonsurgical treatments, depending on individual patient choice. During follow-up, control patients received physical therapy (97.8%), intra-articular steroid injections (73.9%), and RFA of sacral nerve roots (45.7%). The primary outcome measure was 6-month success rate, defined as the proportion of treated subjects with a 20-mm improvement in SIJ pain in the absence of severe device-related or neurologic adverse events or surgical revision. Patients in the control arm could crossover to surgery after 6 months. Baseline scores indicated that the patients were severely disabled, with VAS pain scores averaging 82.3 out of 100 and ODI scores averaging 61.9 out of 100 (0=no disability, 100=maximum disability).
 
At 6 months, success rates were 23.9% in the control group versus 81.4% in the surgical group (posterior probability of superiority >0.999). A clinically important (≥15-point) improvement in ODI score was found in 27.3% of controls compared with 75.0% of fusion patients. Measures of QOL (36-Item Short-Form Health Survey, EuroQol-5D) also improved to a greater extent in the surgery group. Of the 44 nonsurgical management patients still participating at 6 months, 35 (79.5%) crossed over to fusion. Compared to baseline, opioid use at 6 months decreased from 67.6% to 58% in the surgery group, and increased from 63% to 70.5% in the control group (p=0.082). At 12 months, opioid use was similar between groups (55% vs 52%, p=0.61). Although these results generally favored fusion and had high methodologic quality, the trial had a high potential for bias (nonblinded study, subjective outcome measures).
 
In 2016, Sturesson and colleagues reported another industry-sponsored nonblinded RCT of the iFuse Implant System in 103 patients (Sturesson, 2016). Selection criteria were similar to those of the Whang trial, including at least 50% pain reduction on SIJ block. Mean pain duration was 4.5 years. Thirty-three percent of patients had undergone prior lumbar fusion. Nonsurgical management included physical therapy and exercises at least twice per week; interventional procedures (eg, steroid injections, RFA) were not allowed. The primary outcome was change in VAS pain score at 6 months.
 
Of 109 randomized subjects, 6 withdrew before treatment. All patient assigned to iFuse underwent the procedure, and follow-up at 6 months was in 49 of 51 patients in the control group and in all 52 patients in the iFuse group. At 6 months, VAS pain scores improved by 43.3 points in the iFuse group and by 5.7 points in the control group (p<0.001). ODI scores improved by 25.5 points in the iFuse group and by 5.8 points in the control group (p<0.001, between groups). QOL outcomes showed a greater improvement in the iFuse group than in the control group. Changes in pain medication use are not reported. Although these results favored fusion, with magnitudes of effect in a range similar to the Whang RCT, this trial was also not blinded and lacked a sham control. Outcomes were only assessed to 6 months.
 
Subsection Summary: Randomized Controlled Trials
Two fair quality RCTs have reported outcome to 6 months, after which crossover was allowed and comparisons between groups are no longer possible. Both studies reported significantly greater improvements in VAS pain scores and ODI scores in SIJ fusion patients than in control groups. Studies were nonblinded without a placebo control. Pain has a significant subjective and psychologic component. Cognitive behavioral techniques to address pain were specifically excluded from the types of treatment that control subjects could obtain. The change in opioid use in surgical patients was less than would be expected from a procedure that reduced pain by the magnitude shown in the study and did not differ statistically significantly from the control group.
 
Case Series with Good Reported Follow-Up Rates
Case series with good follow-up rates are more likely to provide valid estimates of outcomes. Series with good follow-up rates (>80%) are reported in this section
 
In 2012, Rudolf retrospectively analyzed his first 50 consecutive patients treated with the iFuse Implant System (Rudolf, 2012). There were 10 perioperative complications, including implant penetration into the sacral neural foramen (2 patients) and compression of the L5 nerve (1 patient); these 3 patients required surgical retraction of the implant. At 3 years post-surgery, 1 patient required additional implants due to worsening symptoms. At a minimum of 24 months of follow-up (mean, 40 months), the treating surgeon was able to contact 45 patients. The mean pain score was 2 (1 to 10 scale), and 82% of patients had attained the minimal clinically important difference in pain score (defined as ≥2 of 10).
 
In 2016, results from a case series of 172 patients undergoing SIJ fusion reported to 2 years were published by Duhon Patientsnd colleagues (Duhon, 2016;6, Duhon,  2016;10) were formally enrolled in a single-arm trial (NCT01640353) with planned follow-up for 24 months. Success was defined as a reduction of VAS pain score of 20 mm (out of 100 mm), absence of device-related adverse events, absence of neurologic worsening, and absence of surgical re-intervention. Enrolled patients had a mean VAS pain score of 79.8, a mean ODI score of 55.2, and had a mean pain duration of 5.1 years. At 6 months, 136 (80.5%) of 169 patients met the success end point, which met the pre-specified Bayesian probability of success rate. Mean VAS pain scores were 30.0 at 6 months and 30.4 at 12 months. Mean ODI scores were 32.5 at 6 months and 31.4 at 12 months. At 2 years, 149 (87%) of 172 patients were available for follow-up. VAS pain score at 2 years was 26.0 and ODI score was 30.9. Thus, 1-year outcomes were maintained at 2 years. Other outcomes (eg, QOL scores) showed similar maintenance or slight improvement compared to 1-year outcomes. Use of opioid analgesics decreased from 76.2% at baseline to 55% at 2 years. Over the 2-year follow-up, 8 (4.7%) patients required revision surgery.
 
In 2016, Polly and colleagues reported 2-year outcomes from the RCT of SIJ fusion (Polly, 2016). When reported, without an untreated control group, the study was a case series. Of 102 subjects originally assigned to SIJ fusion and treated, 89 (87%) were evaluated at 2 years. Although the clinical trial used a different composite end point, in this report, clinical outcomes were based on the amount of improvement in SIJ pain and in ODI scores. Improvement was defined as a change of 20 points in SIJ pain score and 15 points in ODI score. Substantial improvement was defined as a change in in 25 points in SIJ pain score or a score of 35 or less and an improvement of 18.8 points in ODI score. At 24 months, 83.1% and 82% had improvement and substantial improvement in SIJ pain score, and 68.2% and 65.9% had improvement and substantial improvement in ODI. By 24 months, the proportion taking opioids was reduced from 68.6% at baseline to 48.3%.
 
A 2014 report by Rudolph and Capobianco described 5-year follow-up for 17 of 21 consecutive patients treated at their institution between 2007 and 2009 (Rudolf, 2014). Of the 4 patients lost to follow-up, 2 had died and 1 had become quadriplegic due to severe neck trauma. For the remaining patients, mean VAS score (range, 0-10) improved from 8.3 before surgery to 2.4 at 5 years; 88.2% of patients had substantial clinical benefit, which was defined as a 2.5-point decrease in VAS score or a raw score less than 3.5. Mean ODI score at 5 years was 21.5. Imaging by radiograph and computed tomography showed intra-articular bridging in 87% of patients with no evidence of implant loosening or migration.
 
Case Series with Unknown Follow-Up Rates
The following case series did not report follow-up rates or study methodologies did not permit calculation of the complete number of patients treated.
 
In 2013, Smith and colleagues retrospectively compared open with minimally invasive SIJ fusion (Smith, 2013). Because all patients received fusion, this study should be interpreted as a case series, with attention paid to the minimally invasive fusion group. Only patients with medical records documenting 12- or 24-month pain scales were included, resulting in 114 patients selected for the minimally invasive group. Losses to follow-up could not be determined. At 12 months, VAS pain scores decreased to a mean of 2.3 from a baseline of 8.1. At 24 months, mean VAS pain score was 1.7, but data for only 38 patients were analyzed. These improvements in VAS pain score were greater than those for open fusion, but conclusions of comparative efficacy should not be made given this type of study. Implant repositioning was performed in 3.5% of patients in the minimally invasive group.
 
A large (N=144) industry-sponsored, multicenter retrospective series was reported by Sachs and colleagues (Sachs, 2014). Consecutive patients from 6 sites were included if preoperative and 12-month follow-up data were available. No information was provided on the total number of patients treated during the same time interval. Mean baseline pain score was 8.6. At a mean 16-month follow-up, VAS score was 2.7 (/10), an improvement of 6.1. Ten percent of patients reported an improvement of 1 point or less. Substantial clinical benefit, defined as a decrease in pain score by more than 2.5 points or a score of 3.5 or less, was reported in 91.9% of patients.
 
In 2016, Sachs and colleagues outcomes of 107 patients with a minimum follow-up of 3 years (Sachs, 2016). The number of potentially eligible patients was not reported, so the follow-up rate is unknown. Pain scores improved from a mean of 7.5 at baseline to 2.5 at a mean follow-up time of 3.7 years. ODI score at follow-up was 28.2, indicating moderate residual disability. Overall satisfaction rate was 87.9% (67.3% very satisfied, 20.6% somewhat satisfied). Revision surgery was reported in 5 (4.7%) patients. Without knowing the number of eligible patients, the validity of this study cannot be determined.
 
2018 Update
A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Sun et al published a meta-analysis of 7 studies that included patients with chronic SIJ pain who received treatment with cooled radiofrequency procedures (Sun, 2018). While overall outcomes were improved after treatment, there was heterogeneity across study designs and patient selection, which limited the strength of the meta-analysis. Also, sample sizes in the selected studies were small.
 
Darr et al published three-year follow-up results of the INSITE and Sacroiliac Joint Fusion with iFuse Implant System trials (Darr, 2018). Of 103 patients with SIJ dysfunction who were treated with minimally invasive SIJ fusion with triangular titanium implants, 60 (72.3%) patients reported an improvement in ODI scores of at least 15 points from baseline to 3 years. The mean ODI score decreased from 56 to 28 for the same timeframe, an improvement of 28 points (p<0.001); similarly, the mean SIJ pain score decreased to 26.2, reflecting a decrease of 55 points (p<0.001). Over 3 years of follow-up, 168 adverse events were reported in 75 patients, although only 22 of these events involved the pelvis. The study was limited by its lack of long-term data from a control group not receiving surgical treatment.
 
Araghi et al published interim results from an industry-sponsored prospective cohort study evaluating pain and ODI outcomes for patients treated for SIJ pain with the SImmetry system (Araghi, 2017). For the 50 patients enrolled at the time of publication, the mean VAS score had decreased from 76.2 at baseline to 35.1 at 6 months after the procedure (p<0.001), with 36 (72%) patients achieving minimal clinically important difference (at least a 20-point reduction). The mean ODI score likewise showed significant improvement from baseline to 6 months, decreasing from 55.5 to 35.3 (p<0.001). Over half of the cohort (56% [n=28]) achieved the minimal clinically important difference (15-point reduction) on the ODI. Prior to surgery, 66% (n=33) of the cohort were on opioids, decreasing to 30% (n=15) at the 6-month follow-up (p<0.001). Quality of life was assessed with the EQ-5D time trade-off index: at baseline, the mean EQ-5D was 0.51, decreasing to 0.69 after 6 months (p<0.001). Likewise, improvements in the Physical and Mental Components Summary scores of the 36-Item Short-Form Health Survey were significantly improved at 6 months, compared with baseline. The strength of findings was limited by the small sample size and short follow-up; without full enrollment of 250 patients, the trial is underpowered to detect contributing factors to fusion and pain relief. Also, the trial does not have a control group. Follow-up data will be published at 1 and 2 years.
 
Cross et al published a case series of 19 patients from 3 centers who underwent minimally invasive SIJ fusion with decortication, placement of bone graft, and fixation with threaded implants (Cross, 2018). At 12 months, bridging bone across the SIJ was observed in 79% (n=15) of patients, increasing to 94% (n=17 of 18 patients with data available) at 24 months. At 24 months postprocedure, 88% (n=15) had fusion within the decorticated area, and the same percentage of patients (88% [n=15]) had solid fusion. While the study was not powered to detect associations between radiographic fusion and clinical outcomes, the authors reported a significant change in the mean numeric rating scale score for pain, from pre-procedure to 24-month follow-up: patients showed an average 73% reduction in low back pain (7.9/10 decreased to 2.1/10, p<0.01; effect size, -2.9). The industry-sponsored study had a small sample size, but provided follow-up data at 2 years after SIJ fusion with a threaded implant, indicating a need for larger comparative studies to confirm the favorable radiographic fusion results suggested by the study.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Chen et al performed a meta-analysis of 5 RCTs comparing RFA to sham or medical treatment in patients with chronic SIJ pain (Chen, 2019). Various RFA procedures were represented, including percutaneous, cooled, and palisade SIJ RF neurotomy. Pain outcomes from all RCTs were pooled for the meta-analysis. Disability outcomes were only available for two studies utilizing cooled RFA. While studies showed no significant heterogeneity for disability outcomes, heterogeneity was high for pain outcomes.
 
Mehta et al published results from a double-blind, randomized, sham-controlled trial assessing the efficacy of radiofrequency neurotomy with a strip-lesioning device in patients with chronic SIJ pain (Mehta, 2019). Seventeen of 30 enrolled patients were randomized to active (n=11) or sham (n=6) treatment. Recruitment was terminated after an interim analysis indicated a statistically significant difference in the pain outcome between groups. After the three-month study endpoint, patients receiving sham treatment were allowed to crossover. While a statistically significant reduction in pain scores was reported at three months, there was no significant difference in functional outcome as measured by the Physical Component Score at three months. Due to the crossover design, it is difficult to gauge long term outcomes and durability of the treatment.
 
Tran et al (2019) published a systematic review comparing the effectiveness of minimally invasive joint fusion (ie, utilizing the iFuse device) compared to screw-type surgeries (Tran, 2019). A total of twenty studies was pooled to calculate a standardized mean difference across pain, disability, and global/quality-of-life outcomes, including 14 studies evaluation the iFuse system and 7 studies evaluated cylindrical, threaded implants. Studies evaluating cylindrical, threaded implants consisted of case series and cohort studies. Patients receiving these implants experienced significantly worse pain outcomes (p=0.03) compared to patients receiving iFuse, with a standardized mean difference of 1.28 (95% CI: 0.47 to 2.09) and 2.04 (95% CI: 1.76 to 2.33), respectively. A statistically significant difference in disability scores was reported between screw-type and iFuse implant groups (0.26 [95% CI: -1.90 to 2.41] vs 1.68 [95% CI: 1.43 to 1.94]; p=0.01), with improved outcomes in the iFuse population. For global/quality-of-life outcomes, a statistically significant difference in scores was reported between screw-type and iFuse implants groups (0.60 [95% CI: 0.33 to 0.88] vs 0.99 [95% CI: 0.75 to 1.24]; p=0.04), with improved outcomes in the iFuse population.
 
 2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Chappell et al performed a meta-analysis of RFA for chronic back pain (Chappell, 2020). The review included 5 RCTs comparing RFA to sham or medical treatment in patients with chronic SIJ pain with follow-up from 1 to 3 months, and 1 study that had follow-up to 12 months. This meta-analysis did not include pulsed RFA. Low quality evidence indicated that RFA led to a modest reduction in pain at 1 to 3-month follow-up, but there was no significant reduction in pain in the single RCT (n=228) that had 6 and 12 mo follow-up (Juch, 2017).
 
Twelve and 24-month results from the iMIA trial were reported by Dengler et al (Dengler, 2017; Dengler, 2019). Twenty-one patients in the conservative management group had little or no improvement in symptoms and crossed over to SIJ fusion after the 6-month visit. These were analyzed with the last observation prior to crossover carried forward. At 12 months, low back pain had improved by 42 points (standard deviation [SD], 27.0) on a 100-point VAS in the SIJ fusion group compared with 14 points (SD=33.4) in the conservative management group (p<0.001). At 24 months back pain had improved by 45 points compared to 11 points in the control group, with 79% (37 of 47) of SIJ fusion patients achieving at least a 20-point improvement compared to 24% (11 of 46) of controls. At 24 months there was an improvement of 26 points in ODI compared to 8 points in controls (p<0.001). Improvement of at least 20 points was observed in 64% of the SIJ fusion group compared to 24% of the conservative management group.
 
In general, cohort studies and case series have shown improvements in VAS pain scores and other outcomes measures consistent in magnitude to the RCTs. The Long-Term Outcomes from INSITE and SIFI (LOIS) trial was a prospective single-arm study that enrolled patients who had participated in 2 of the studies for evaluation at 3, 4, and 5 years (Whang, 2019). The primary success outcome, a reduction in VAS of at least 20 points in the absence of a serious device-related adverse event, neurologic worsening, or surgical revision, was obtained in 81.7% (95% confidence interval 72.4 to 89.0%) of patients at 5 years. The improvements in other clinical outcomes were maintained out to 5 years. Opioid use decreased over time, although the contribution of the opioid use agreement cannot be determined. Fifteen percent of patients were no working due to back pain. Radiolucency suggesting implant failure were observed in 5% of cases and were associated with incorrect placement. Bridging bone was observed in 45% of sides at 12 months, 71% at 24 months, and 88% at 60 months.
 
The Study of Bone Growth in the Sacroiliac Joint after Minimally Invasive Surgery with Titanium Implants (SALLY) is a 5-year multicenter study that will assess non-inferiority of outcomes with a 3-D printed triangular implant as compared to the traditionally manufactured titanium coated implant. Twelve-month follow-up has been published for 46 of the 51 patients enrolled (Patel, 2020). The 6-month change in ODI met the non-inferiority margin, and secondary outcomes of pain, disability, and QOL were similar to those obtained in the INSITE, iMIA, and SIFI trials. Independent radiographic analysis showed bridging bone in 70% and 77% of sides imaged at 6 and 12 months, respectively, compared to 45% bridging bone in prior studies with the solid titanium coated implants. No breakage, migration, or subsidence was detected. However, there was no evidence that the increase in bridging bone led to an improvement in pain or functional outcomes compared to the milled implant at 12 months. Follow-up is continuing.
 
December 2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. The key identified literature is summarized below.
 
Sacroiliac Joint Fusion/Fixation With a Transiliac Triangular Implant
Martin et al (2020) published a systematic review of the current literature and clinical outcomes of SI joint fusion surgery. Two approach types (dorsal and lateral) and several different implants were identified. Most studies included level 4 data. There are two prospective level 1 studies which support the triangular titanium minimally invasive SI joint fusion through the lateral approach. The two level 1 studies are Dengler et al (2017) and Polly et al (2016).  Both studies showed significant benefit in carefully selected patients in pain improvement and adverse outcomes were similarly low in both studies.
 
Sacroiliac Joint Fixation/Fusion With an Implant Other Than a Transiliac Triangular Implant
A qualitative systematic review by Lorio et al (2020) for the International Society for the Advancement of Spine Surgery found evidence on the safety and effectiveness of distraction (posterior) SIJ fusion was limited to 1 prospective multicenter study (described below), no comparative studies, and a small number of case series.
 
Rappoport et al (2017) reported an industry-sponsored prospective study of SIJ fusion with a cylindrical threaded implant (SI-LOK). The study included 32 patients using a diagnosis of SIJ dysfunction who had failed nonoperative treatment, including medication, physical therapy, and therapeutic injections. A diagnostic injection was performed to confirm the source of pain to the SIJ. The procedure included drilling to prepare for screw insertion and implantation of 3 screws, at least 1 of which was slotted. The slotted screws were packed with an autogenous bone graft from the drill reamings. Pain and disability scores were reduced following device implantation (see Table 18), and revisions within the first 12 months of the study were low (n=2). At the 2 year follow-up, VAS scores remained low, although 4 (12.5%) did not return for follow-up and 2 patients required revision surgery; analysis did not count these as treatment failures (Rappaport et al, 2021)
 
Fuchs and Ruhl (2018) published 2-year results of a prospective multi-center cohort of the posterior approach to arthrodesis of the SIJ. A total of 171 patients from 20 hospitals in Germany were treated from 2011 to 2012 using a DIANA implant (marketed in the U.S. as the NADIA implant). The DIANA implant is a hollow, tapered dowel that comes in diameters of 13, 15, 17, or 19 mm. A distraction tool was used to determine the size of the implant, which is inserted between the ilium and sacrum under distraction. Allogeneic bone grafts were used in 66% of cases. Patients had partial weight bearing on the operated side for 6 to 8 weeks. At the 2 year follow-up, VAS had decreased from 74 to 37, ODI improved from 51% to 33%, and the McGill Pain Questionnaire decreased from 50% to 31% (all p<.001). Use of opioids decreased from 49.3% of patients to 30.3% at follow-up. In computed tomography (CT) scans, only 31% of patients showed SIJ fusion at 2 years.
 
International Society for the Advancement of Spine Surgery
In 2020, the International Society for the Advancement of Spine Surgery provided guidance on indications for minimally invasive SIJ fusion with placement of lateral transfixing devices (Lorio et al, 2020).
 
The Society recommended that "patients who have all of the following criteria may be eligible for lateral MIS SIJF with placement of lateral transfixing devices:
    • "Chronic SIJ pain (pain lasting at least 6 months)
    • Significant SIJ pain that impacts QOL or significantly limits activities of daily living
    • SIJ pain confirmed with at least 3 physical examination maneuvers that stress the SIJ [list provided above] and reproduce the patient’s typical pain
    • Confirmation of the SIJ as a pain generator with > 50% acute decrease in pain upon fluoroscopically guided diagnostic intra-articular SIJ block using a small volume (< 2.5 mL) of local anesthetic......
    • Failure to respond to nonsurgical treatment consisting of NSAIDs and a reasonable course (4–6 weeks) of PT. Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability"
    • It was recommended that intra-articular SIJ steroid injection and radiofrequency ablation (RFA) of the SIJ lateral branch nerves may be considered but are not required.
Specifically not recommended were:
    • Minimally invasive posterior (dorsal) SIJ fusion
    • Repeat intra-articular steroid injection
    • Repeat SIJ radiofrequency ablation.
 
American Society of Pain and Neuroscience
In 2021, the American Society of Pain and Neuroscience published practice a guideline on radiofrequency neurotomy.46, All of the workgroup members utilized radiofrequency neurotomy in clinical practice. A consensus statement, based on Grade II-1 evidence (well-designed, controlled, nonrandomized clinical trial), was that "lateral branch radiofrequency neurotomy may be used for the treatment of posterior sacral ligament and joint pain following positive response to appropriately placed diagnostic blocks."
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Patel et al randomized 72 patients with SIJ pain and sacroiliac joint dysfunction to fluoroscopy-guided intra-articular injection of corticosteroid and local anesthesia or a sham group consisting of fluoroscopy-guided anesthetic injection and distilled water injection (Patel, 2023). Diagnosis of sacroiliac joint dysfunction was based on the International Association for the Study of Pain criteria. All patients reported pain located over the SIJ. In a single-blinded assessment, pain (Numeric Rating Scale [NRS]) and disability (Oswestry Disability Index [ODI]) were significantly reduced at 4 weeks follow-up within each group, but the corticosteroid injection group had a significantly greater magnitude for both outcomes (p<.001).
 
In a RCT by Cohen et al, 210 patients with sacroiliac joint pain lasting 3 or more months were randomly assigned to receive cooled radiofrequency ablation or standard medical management (Cohen, 2023). The primary outcome measure was mean reduction in low back pain score on a 0-10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function. 3 months post-treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction0.4±1.7) in the standard medical management group (p<0.0001). 52.3% of subjects in the cooled radiofrequency ablation group experienced > 2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients(p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL-5 score 0.68±0.22 vs 0.47±0.29; p<0.0001). In patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management.
 
Caldoney et al reported an interim analysis of a single-arm prospective study of posterior SIJ fusion with the LinQ implant platform for sacroiliac joint stabilization and arthrodesis (Caldoney, 2022). The multi-center study included 77 patients treated from January 2020 to March 2022 who were followed for 6 months (n=69); the trial aims to enroll 159 participants. Patients had a mean age of 60.3 years and had experienced SIJ pain for a mean of 4.9 years, with mean baseline VAS and ODI scores of 74.6 and 51, respectively. The average VAS improvement from baseline was 34.9 (SD, 28.9; p<.001) and 47 (68%) participants had a greater than 20 mm improvement on the VAS, and 52% showed>50% pain relief at 6 month follow-up. ODI scores improved by a mean of 17.7 (SD, 18.8; p<.001), and 39 (57%) of participants had an improvement greater than 15 points. Another endpoint investigated by the authors was the Patient-Reported Outcomes Measurement Information System (PROMIS-29 item) instrument, which showed significant (p<.001) improvements from baseline values in all 7 subscales (Pain interference, sleep disturbance, fatigue, anxiety, depression, ability to participate in social roles and activities, and physical functioning). A total of 2 adverse events, including 1 serious adverse event and 1 death, were reported through 6 months of follow-up, but none were determined as being related to the procedure. The main limitations of this study are a lack of a comparison group and the interim nature of the analysis, resulting in a lower number of participants and shorter duration of follow-up.
 
Kucharzyk et al published interim results from a prospective cohort study evaluating pain and ODI outcomes for patients treated for SIJ pain with the SImmetry sacroiliac joint fusion system (NCT02074761) (Kucharzyk, 2022). A total of 250 participants were recruited from 23 centers in the U.S; of these 80.4% (n=201) were available for 1 year follow-up, although not all patients have each outcome reported due to incomplete follow-up. The mean age of the participants was 60.5 years of age, and each participant had SI joint pain for 6 months or greater, and most had prior treatment for SIJ pain, including some prior lumbar spinal procedures. The mean VAS score had decreased from 76.4 at baseline to 33 at 1 year after the procedure (p<.001), with 140 (72.2%) patients achieving minimal clinically important difference (≥20-point reduction). The mean ODI score likewise showed significant improvement from baseline to 1 year, decreasing from 54.4 to 30.5 (p<.001). Over half of the cohort (62.5% [n=120]) achieved the minimal clinically important difference (15-point reduction) on the ODI. Before surgery, 62.7% (n=126) of the cohort were on opioids, decreasing to 26.9% (n=54) at the 1 year follow-up (p<.001). QOL was assessed with the EQ-5D: at baseline, the mean EQ-5D was 60.9, increasing to 72.8 after 1 year (p<.001). The authors reported 8 (3.2%) of patients had a serious adverse event, of which 5 were determined to be device-related (back pain, pain in the extremity, bilateral SI joint pain, device loosening, or device malposition). The main limitations of this study are a lack of comparison group and incomplete follow-up on all patients due to the interim nature of this analysis.
 
In 2022, ASPN published guidance on the treatment of lower back pain (Sayed, 2022).
 
The following recommendations were provided concerning SIJ injections, minimally invasive sacroiliac joint fixation and sacroiliac radiofrequency ablation:
 
    • Sacroiliac joint injections have been associated with positive predictive value in the diagnosis of SIJ dysfunction (Grade, A; Level, I-A; Level of certainty, Strong)
    • Sacroiliac joint injections demonstrate short term relief of SIJ dysfunction (Grade, B; Level, I-B; Level of certainty, Moderate)
    • Minimally invasive sacroiliac fusion (Grade, A; Level, 1-A; Level of certainty, High)
    • SI joint denervation/ablation is effective in treatment of SI joint dysfunction pain and is superior to sham in RCT (Grade, A; Level, I-A; Level of certainty, High)
 
In 2022, NICE published medical technology guidance on using the iFuse implant system for treating chronic sacroiliac joint pain. It provided the following recommendations (NICE, 2022):
 
1.1 iFuse implant system is recommended as an option for treating chronic sacroiliac joint pain.
1.2 iFuse should be considered for use in people with a confirmed diagnosis of chronic sacroiliac joint pain (based on clinical assessment and a positive response to a diagnostic injection of local anesthetic in the sacroiliac joint) and whose pain is inadequately controlled by non-surgical management.
CPT/HCPCS:
22899Unlisted procedure, spine
27096Injection procedure for sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy or CT) including arthrography when performed
27278Arthrodesis, sacroiliac joint, percutaneous, with image guidance, including placement of intra articular implant(s) (eg, bone allograft[s], synthetic device[s]), without placement of transfixation device
27279Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device
27299Unlisted procedure, pelvis or hip joint
64451Injection(s), anesthetic agent(s) and/or steroid; nerves innervating the sacroiliac joint, with image guidance (ie, fluoroscopy or computed tomography)
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