| Coverage Policy Manual | |
| Policy #: | 2018010 |
| Category: | Surgery |
| Initiated: | February 2018 |
| Last Review: | January 2024 |
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| Ablation of Soft Tissue (eg, Radiofrequency Coblation, Ultrasonic Ablation) for Musculoskeletal Conditions | |
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| Description: |
Radiofrequency Coblation
RF coblation uses bipolar low-frequency energy in an electrically conductive fluid (eg, saline) to generate a high-density plasma field around the energy source. This creates a low temperature field of ionizing particles that break organic bonds within the target tissue. Coblation technology is used in a variety of surgical procedures, particularly related to otolaryngology and orthopedics. The proposed advantage of coblation is that the procedure provides for controlled and highly localized ablation, resulting in minimal damage to surrounding tissue. RF coblation was also found to exhibit several properties that may make it an attractive option for addressing the underlying pathophysiology of chronic tendinopathies, namely increased angiogenesis, reduction of inflammatory responses, and increased expression of growth factors (Tay et al, 2012). RF coblation surgical wands are utilized by orthopedic surgeons in minimally invasive arthroscopic procedures to facilitate soft tissue debridement, subacromial decompression, meniscal removal and sculpting, or tendon debridement.
Ultrasonic Ablation
The use of percutaneous ultrasonic ablation has been proposed for a variety of soft tissue conditions including: Achilles tendinosis, lateral or medial elbow tendinosis, patellar tendinosis, recalcitrant plantar fasciitis, and rotator cuff or shoulder tendinosis as well as other chronic or degenerative conditions of the musculoskeletal system involving fascia or tendons of the ankle, foot, elbow, hip, knee, shoulder, or wrist.
Tendinopathy
Tendinopathy is a clinical pain syndrome characterized by tendon thickening due to proliferation and chronic irritation of neovascular repair tissue with a history of repetitive tendon loading. This condition commonly results from overuse and has a high incidence rate in athletes and laborers. Clinical history should clarify predisposing training or activity and assess the level of functioning. Biomechanical abnormalities during activity should be identified and corrected. Standard treatment may, therefore, consist of biomechanical modification, activity modification, physical therapy (eg, heavy load resistance training), and nonsteroidal anti-inflammatory medication. For chronic tendinopathies, glucocorticoids
should only be used in select cases (eg, rotator cuff tendinopathy). Surgical consultation following six months of a well-designed physical therapy program with adjunct medical treatments can be considered if there is no improvement in pain or function (Davenport et al, 2005). Validated and reliable functional assessment scores should be utilized by the clinician to grade symptoms and assess patient function. Examples of suitable scales include the Victoria Institute of Sport Assessment for Achilles tendinopathy (Robinson et al, 2001). Surgical approaches may involve incisions to the paratendon and removal of adhesions and degenerate tissue. Longitudinal incisions may be made in the tendon to promote a repair response. This latter strategy has also been delivered via minimally invasive arthroscopic approaches (Lohrer, 2016; Nirschl, 1979). These approaches may also address the debridement of the neovascular supply to the tendon surface. Collectively, a prolonged recovery duration to accommodate tendon healing may be required with these interventions.
Plantar Fasciitis
Plantar fasciitis is a musculoskeletal condition characterized by pain in the plantar region of the foot that worsens upon initiation of walking and with local point tenderness elicited during a clinical examination. Radiographic and ultrasonographic studies are not typically indicated for primary diagnosis but may be useful in ruling out alternative causes and visualizing the thickening of the plantar fascia. Initial standard therapy may consist of stretching exercises, orthotics, activity and lifestyle modification, nonsteroidal anti-inflammatory drugs, splints or casts, and glucocorticoid injections. The vast majority of patients improve without surgery. Surgery is generally considered a last line of therapy and is reserved for individuals who do not respond to at least 6 to 12 months of initial, nonsurgical therapy. Surgical approaches include variations of open or endoscopic, partial or complete, plantar fascia release which may or may not include calcaneal spur resection, excision of abnormal tissue, and nerve decompression. The use of RF microtenotomy during open or percutaneous surgery has been explored alone or in combination with plantar fasciotomy (Chou et al, 2016). Plantar fasciitis is one of the most common causes of foot and heel pain in adults. It is estimated to be responsible for approximately one million patient medical visits per year in the U.S. (Riddle, 2004). The peak incidence of the condition in the general population occurs between ages 40 and 60. There is a higher incidence rate among runners with a younger age of onset. The etiology of plantar fasciitis is poorly understood and may be multifactorial in nature. Contributing risk factors may include obesity, prolonged standing or activity, flat feet, and reduced ankle dorsiflexion (Riddle et al, 2003; Rano, 2002). Plantar fasciitis has been reported in association with fluoride use for the treatment of osteoporosis (Riggs, 1980). Differential sources of foot and heel pain may include Achilles tendinopathy, stress fractures due to osteoporosis, rheumatoid arthritis, peripheral neuropathies associated with diabetes, extrinsic factors (eg, inappropriate footwear), aging, and structural disorders.
Lateral Epicondylitis
Lateral epicondylitis, also known as tennis elbow, represents chronic tendinosis of the myotendinous group of the lateral epicondyle characterized by pain and disability. The incidence in the general population may approach 1 to 3 percent (Shiri et al, 2006). Risk factors include smoking, obesity, forceful activity, and repetitive activity for at least two hours daily. Lateral epicondylitis is characterized by injury to the extensor carpi radialis brevis or extensor digitorum communis muscles. The condition is diagnosed through findings of localized tenderness and pain with clinical examination. Initial conservative management includes modification of activity and biomechanics, counterforce bracing or splinting, nonsteroidal anti-inflammatory drugs, and physical therapy (Struijs et al, 2004). Surgical referral is typically reserved for patients with severe symptoms that do not improve despite compliance with an appropriately designed physical therapy program for at least six months.
Regulatory Status
In 2014, the TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch, an electrosurgical cutting and coagulation device (ArthroCare Corporation, K140521), was cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process, on the basis of an earlier predicate device (ArthroCare Topaz Wand, K080282, 2008). The surgical wands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, including fasciotomy, synovectomy, tenotomy, and capsulotomy of the foot and tenotomy of the knee, wrist, elbow, ankle, shoulder, and rotator cuff. Food and Drug Administration product code: GEI.
The TX1 Tissue Removal System and the Tenex Health TX System are ultrasonic surgical aspirators that irrigate, fragment, emulsify and aspirate soft tissue and are proposed for use in the treatment of recalcitrant tendinopathy or plantar fasciopathy. The Tenex Health TX System is identical to the predicate TX1 Tissue Removal System in its mode of operation and FDA-cleared indications for use. Only minor technological differences are noted when comparing the device systems.
In March 2013, the TX1 Tissue Removal System (Tenex Health, Inc., Lake Forest, CA) received U.S. Food and Drug Administration (FDA, 2013) 510(k) clearance (K12364) as "an ultrasonic surgical aspirator" to emulsify and remove soft tissue. In March 2016, the Tenex Health TX® System (K153299) (Tenex Health, Inc., Lake Forest, CA) received 510(k) clearance as substantially equivalent to the predicate device, the TX1 Tissue Removal System. Both systems are intended for use with a TX2 MicroTip in "surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable."
Related Policies:
2000057 - Extracorporeal Shock Wave Therapy for Plantar Fasciitis and Other Musculoskeletal Conditions
2016008 - Thermal Ablation of Peripheral Nerves to Treat Pain Associated with Plantar Fasciitis, Knee Osteoarthritis, Sacroiliitis and Other Conditions
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Policy/ Coverage: |
Effective February 2020
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of minimally invasive ablation procedures, radiofrequency coblation, and ultrasonic ablation of soft tissue (percutaneous or by other means) do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. as a treatment for musculoskeletal conditions, including but not limited to the following conditions:
For members with contracts without primary coverage criteria, the use of minimally invasive ablation procedures, radiofrequency coblation, and ultrasonic ablation of soft tissue (percutaneous or by other means) are considered investigational as a treatment for musculoskeletal conditions, including but not limited to the following conditions:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Note: If a tenotomy, fasciotomy or fasciectomy code is used to represent minimally invasive ablation procedures, radiofrequency coblation, or ultrasonic ablation of soft tissue, the coverage statements in this policy will apply.
Effective Prior to February 2020
The use of ultrasonic ablation of soft tissue (percutaneous or by other means) for any condition including but not limited to plantar fasciitis, elbow tendinosis, patellar tendinosis, shoulder/rotator cuff tendinosis, and Achilles tendinosis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of ultrasonic ablation of soft tissue (percutaneous or by other means) for any condition including but not limited to plantar fasciitis, elbow tendinosis, patellar tendinosis, shoulder/rotator cuff tendinosis, and Achilles tendinosis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Note: If a tenotomy, fasciotomy or fasciectomy code is used to represent percutaneous ultrasonic ablation, the coverage statements in this policy will apply.
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| Rationale: |
This policy has been updated regularly with searches of the MEDLINE database. The most recent literature review was performed through October 3, 2019. Following is a summary of the key literature to date.
RADIOFREQUENCY COBLATION
Plantar Fasciitis
Comparative Cohort Studies
Wang et al (2017) published the results of a retrospective, cohort study evaluating outcomes with endoscopic plantar fasciotomy (n=12) compared to RF microtenotomy (n=22) for recalcitrant plantar fasciitis at a single-center from 2007 to 2015. Prospectively collected data from 34/58 patients undergoing either procedure were included in this study as they had a complete data set with 1 year of follow-up. Patients were required to fail a conservative treatment program of at least six months in duration. TheAOFAS hindfoot score scale (total score [HINDTOT], visual analog scale pain score [HINDVAS]) and the patient-reported SF-36 were administrated pre-operatively and at 3, 6, and 12 months post-operatively.
There was no difference in baseline outcome measures. At 3 months, patients receiving endoscopic plantar fasciotomy had better results compared to patients receiving open RF microtenotomy, with statistically significant improvement in visual analog pain scores (HINDVAS; 0.9 vs 3.3; p=0.027) and patient-reported social-functioning (92.5 vs 71.3; p=0.030) and role-functioning-emotional (93.3 vs 80.4; p=0.030). At six months and one year post-treatment, no significant differences between treatment groups were noted. HINDVAS scores decreased from 7.2 to 1.3 and 7.3 to 0.9 over 1 year in fasciotomy and RF microtenotomy groups, respectively. Complications consisting of reports of persistent
postoperative pain, recurrence of pain at 6 months, and recurrence of pain at 1 year were 0% vs 9.1%, 8.3% vs 13.6%, and 16.7% vs 13.6% in fasciotomy and RF microtenotomy groups, respectively.
Chou et al (2016) evaluated outcomes in patients undergoing plantar fasciotomy, RF microtenotomy, or both procedures between 2007 and 2014 at a single-institution. Patients were required to fail conservative therapy and contain a full data set with one year of follow-up to be included for analysis. Patients were evaluated preoperatively and at 6 months and 1-year post-treatment with the AOFAS Ankle-Hindfoot Scale and SF-36 Health Survey. A total of 27 feet (n=27 patients) underwent plantar fasciotomy, 55 feet (n=48 patients) underwent RF microtenotomy, and 9 feet (n=9 patients) underwent both procedures. The rate of complications consisting of consistent heel pain at 1 year in each group was 11%, 7.3%, and 33%, respectively. Differences in complications between groups were not found to be statistically significant (p=0.069). No significant differences were reported between groups for all outcomes measured at each time point. HINDVAS pain scores (standard deviation [SD]) at baseline and 1 year were 7.407 (1.185) vs 1.963 (2.653), 7.352 (1.580) vs 1.585 (2.389), and 7.667 (2.000) vs 0.556 (1.333) for fasciotomy, RF microtenotomy, and combination groups, respectively.
Tay et al (2012) conducted a prospective cohort study comparing percutaneous RF microtenotomy (n=27) and open RF microtenotomy (n=32) in patients with plantar fasciitis. Outcomes were measured with the AOFAS Ankle-Hindfoot scale scores and SF-36 Health Survey at baseline and 3, 6, and 12 months post-treatment. At three months, there was no significant difference in HINDVAS pain scores and AOFAS HINDTOT between groups. However, the SF-36 reported a statistically significant difference in bodily pain between the open (59.2) and percutaneous (44.2) groups (p=0.017). At six months, there were no significant differences in HINDVAS pain scores and AOFAS HINDTOT between groups. However, SF-36 component scores for vitality (72.0 vs 56.5; p=0.007), functioning (emotional) (100.0 vs 75.6; p=0.006), and mental health (84.4 vs 74.9; p=0.049) fared significantly better in the percutaneous vs open RF microtenotomy groups. While it is unclear to what extent these findings correlate with baseline differences in SF-36 mental health findings (84.0 vs 74.25; p=0.028), no significant differences in SF-36 outcome measures were detected at 12 months between groups. SF-36 score for role functioning (physical) were pooled for analysis. Scores increased from 25.0 at baseline to 68.8 at 12 months (p=0.009). At 12 months, the open group had a significantly lower pain score of 0.78 vs 3.00 in the percutaneous group (p=0.035) but the AOFAS hindfoot score was not significantly different (74.9 vs 87.0; p=0.159).
Case Series
Several small case series have addressed the use of RF microtenotomy for plantar fasciitis.15,16,17, Sean et al (2010) conducted a prospective, single-center pilot study in 14 patients with plantar fasciitis and failed conservative treatment of at least 6 months in duration.17, AOFAS ankle-hindfoot and SF-36 Health Survey scores were assessed at baseline and 3 and 6 months post-treatment. Mean AOFAS hindfoot scores improved from 34.47 to 69.27 and 71.33 at 3 and 6 months (p=0.00). There was a significant decrease in SF-36 bodily pain ratings (p=0.01), and significant increases in physical (p=0.01) and social function (p=0.04) scores. Twelve out of 14 (85.7%) of patients reported good to
excellent satisfaction with their results at 6 months and 12 out of 14 (85.7%) had their expectations met at 6 months of follow-up. No peri- or postoperative complications were
reported.
Lateral Epicondylitis and Wrist Tendinopathy
Randomized Clinical Trials
Lee et al (2018) conducted an RCT comparing the clinical effects of open RF microtenotomy (n=22) and arthroscopic release of the ECRB tendon (n=24) in patients with refractory lateral epicondylitis that had failed 2 or more corticosteroid injections, extracorporeal shock-wave therapy, and conventional treatment for least 6 consecutive months. Preoperative MRI of the elbow was performed in all patients to assess for intra-articular or ligamentous lesions. The primary outcome was the Mayo Elbow Performance Score (MEPS) at 24 months post-procedure. Additional outcome measures included the VAS score for pain, flexion-extension arcs and grip strength, and the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH) at 3, 6, 12, and 24 months post-surgery. Fifty-five patients were randomized and 9 patients were lost to follow-up, leaving 46 patients for analysis. One complication consisting of persistent postoperative pain was reported in the arthroscopic release group and one complication consisting of postoperative ECRB rupture was reported in the RF microtenotomy group. Both patients recovered following revision surgery. Patients in both groups showed statistically significant functional improvement with regard to grip strength and DASH, VAS, and MEPS scores at two years (p<0.05). Differences between groups were not statistically significant. The mean operation time was significantly shorter for the RF microtenotomy group (mean (SD); 15.6 (3.6) vs 41.4 (5.2) min; p<0.001). Three patients (12.5%) in the arthroscopic release group and 2 patients (9.1%) in the RF microtenotomy group reported persistent pain or discomfort with a MEPS score <90 at 2 years.
Hamlin et al (2018) published the results of an RCT comparing RF microtenotomy (n=21) with standard open release surgery (n=18) for refractory lateral epicondylitis., Themerical Rating Scale (NRS pain scores and DASH scores were evaluated at baseline, 6 weeks, 6 months, and 12 months. Grip strength was assessed at baseline and six weeks. The primary outcome measure was the NRS pain score at 12 months. NRS pain scores improved significantly in both groups at all time points. There was a significant
difference between RF microtenotomy [mean (SD); -2.285 (0.5174)] and open release surgery [-4.689 (0.6012); p=0.0021] at 6 weeks only. Grip strength improved by 31% in the RF microtenotomy group compared to 38% in the open release surgery group, however, there were no significant differences between initial and 6-week scores nor between groups. Two patients (9.5%) that received RF microtenotomy opted to receive open release surgery after the final assessment of the study due to persistent symptoms. Two patients (11.1%) that received open release surgery also reported persistent symptoms at 1 year. The study investigators indicate that since RF microtenotomy provides no clear
treatment or risk-benefit, surgical candidates should be offered open release surgery.
Meknas et al (2013) randomized patients to either open release surgery (n=11) or RF microtenotomy (n=13) for treatment of refractory lateral epicondylitis following the failure of 1 year of conservative treatment. Outcome measures included VAS pain scores, grip strength, and MEPS score functional assessment. Select patients were also evaluated via MRI and dynamic infrared thermography. One patient in the open release group died prior to mid-term follow-up. One patient in the RF microtenotomy group was excluded due to revision open release surgery. Mean follow-up for the open release group was 75.5 months (SD, 8.1 months) and 68.4 months (SD, 6.2 months) for the RF microtenotomy group
(p=0.02). NRS scores decreased significantly for both groups with no statistically significant differences between groups at baseline or mid-term follow-up. Grip strength increased in both groups but was not found to be significant or significantly different between groups. Median MEPS scores improved significantly in both groups with no significant differences between treatments. Dynamic infrared thermography revealed seven hot spots in each group preoperatively. At medium-term follow-up, the number of detected hot spots was reduced to 1 in the open release group (p=0.041) and 4 in the microtenotomy group (p=0.092). Differences in the total number of hot spots between groups were not significant.
Achilles Tendinopathy
Randomized Clinical Trials
Morrison et al (2017) conducted a single-blinded RCT evaluating RF coblation microdebridement compared to surgical decompression for patients with noninsertional Achilles tendinopathy who had failed a conservative management program of at least 6 months in duration. The primary outcome measure was the difference in VAS pain score at six months. The secondary outcome measure was the VISA-A score. The control group had significantly less severe symptoms as indicated by higher VISA-A scores and lower VAS scores at baseline. Both groups demonstrated statistically significant improvements in scores at six months, with no significant differences noted between groups (p>0.05). The analysis of covariance was adjusted for age, sex, and BMI. Not all study subjects demonstrated improvement in their VAS scores. In the control group, 2 patients (12.5%) reported worsening of pain (12.5%) and 1 (6.25%) reported no change. In the RF microdebridement group, 2 patients (10%) reported worsening of pain and 4 (20%) reported no change. Two patients (12.5%) reported a decrease in VISA-A score following decompression surgery compared to 5 patients (25%) in the RF microdebridement group. Complications
included two cases of superficial wound infection in the decompression group and one partial Achilles rupture in the RF microdebridement group. Study investigators concluded there was no added benefit for the use of RF microdebridement and have discontinued its use in their practice.
Retrospective Studies
Shibuya et al (2012) conducted a retrospective review of institutional patient cases to elucidate the safety and efficacy of percutaneous RF coblation for the treatment of insertional Achilles tendinopathy between 2005 and 2011. Forty-seven patients were identified ranging in age from 23 to 76. The mean BMI was 37.1 (SD, 6.96) with a mean follow-up duration of 8.6 months (range, 1 to 40). Revision surgery was performed in 15% of patients. Twenty-six patients (55%) had at least 3 months of follow-up data available, and revision surgery was performed in 23%. Study authors believe these higher than typical rates of reoperation indicate that a percutaneous approach may not be as effective as an open technique. Furthermore, patients in this study had a high mean BMI, whereas other studies addressing foot and ankle tendinopathies have typically excluded patients with a BMI >35 due to a known correlation with poorer outcomes.
Shoulder and Rotator Cuff Tendinopathy
Randomized Clinical Trials
Al-Ani et al (2019) performed a small RCT evaluating arthroscopic subacromial acromioplasty (n=14) compared to RF microtenotomy (n=13) for the treatment of rotator cuff tendinopathy in patients with a minimum symptom duration of 6 months.24, About half of patients in each arm had previously received one to three corticosteroid injections at least six months prior to inclusion. The main outcome measures included VAS pain scores, functional Constant scores, and strength measures through two years. Significant pain reductions were reported at 12 weeks, 6 months, and 2 years, with no significant differences between groups. Treatment harms were not reported.
Lu et al (2013) randomized patients with shoulder impingement syndrome and rotator cuff tendinopathy to receive either arthroscopic subacromial decompression alone (n=40) or in combination with RF microtenotomy (n=40) using the TOPAZ microdebrider (ArthroCare) after failing a conservative management program of at least 5 months in duration. Outcome measures included VAS pain scores at three weeks, six weeks, three months, six months, and one year. Functional outcomes included a range of motion, American Shoulder & Elbow Surgeon’s score, Simple Shoulder Test questionnaire, UCLA score, and Constant-Murley score at three months, six months, and one year. Sixty-five out of 80 patients (81.3%) were available for final follow-up at 1 year. Pain scores decreased significantly at three weeks postoperatively for both treatment groups. While there was a significant difference between group pain scores at three weeks, the combination group did not meet the threshold for a clinically meaningful reduction in pain at this early time point compared to subacromial decompression only. Scores continued to improve over time with no significant difference between groups. For functional measures (American Shoulder & Elbow Surgeon’s score, UCLA, Simple Shoulder Test questionnaire, Constant-Murley, range of motion), scores improved significantly for both groups with no significant differences between groups at any postoperative time point. The authors noted that they did not detect any added benefits for the addition of RF microtenotomy to the standard surgical procedure. The study is limited by a high loss to follow-up, the use of an independent observer that was not blinded to treatment assignment, and lack of reporting on harms.
Patellar Tendinopathy
Randomized Clinical Trials
Owens et al (2002) randomized patients with symptomatic patellar chondral lesions to RF coblation microdebridement (n=19) or mechanical debridement (n=20).25, All patients had failed a six-month course of conservative treatment. The primary outcome measure was the Fulkerson-Shea Patellofemoral Joint Evaluation Score, which pain, functional, and clinical outcomes into an overall performance score. A score of 100 indicates a perfect score. While RF microdebridment achieved statistically higher scores at one and two years of follow-up, a clinically meaningful difference was not prespecified and pain outcomes were not directly assessed. Furthermore, the incidence of crepitus in the afflicted knee was 55% for RF microdebridment compared to 32% for mechanical debridement after 2 years. This study was further limited by restricting enrollment to female patients only and not blinding the independent observer to treatment assignments.
ULTRASONIC ABLATION
Patel (2015) reported on a prospective case series study in which patients were allowed either to continue with noninvasive treatment or to undergo focal aspiration and partial fasciotomy with an ultrasonic probe (TX1). Inclusion criteria for the study was plantar fasciitis symptoms lasting 12 months or longer. Twelve patients with refractory plantar fasciitis chose the procedure. All patients had failed conservative care, including physical therapy, casting, shock wave therapy, and invasive procedures such as injections and endoscopic plantar releases. Four of the 12 had undergone an open or endoscopic partial release at a different institution but had experienced no improvement in symptoms. American Orthopaedic Foot and Ankle Society (AOFAS) scores were obtained before and after surgery. Follow-up consisted of clinic visits 2 weeks after surgery and monthly thereafter. The 12 patients had a mean preoperative AOFAS score of 30 (range of 17-46) and a mean postoperative score of 88 (range of 25-92). By the 3 month postoperative visit, symptoms were resolved in 11 patients (no activity restricted by plantar fascia pain). On physical examination, 11 patients had no palpable tenderness at the site of preoperative pain. Pain relief was documented as having occurred between 5 and 13 weeks after treatment. One patient had bilateral procedures. The author concluded that this was the first report of a plantar fascia partial release guided by ultrasonic energy delivered by a percutaneously inserted probe under local anesthesia and that the procedure appears to be a safe, effective, well-tolerated treatment for a condition that is refractory to other options. The author also acknowledged that more studies are needed to further validate the safety and efficacy of this treatment modality.
Sanchez et al (2017) reported on a case series study on the complications associated with percutaneous ultrasonic tenotomy as a treatment for chronic Achilles tendinosis. The authors reported that percutaneous ultrasonic tenotomy is a relatively new treatment option for many types of tendinopathy and concluded that when considering percutaneous ultrasonic tenotomy, surgeons should be cognizant that it is a surgical procedure with complications similar to those of other Achilles tendon surgeries.
Koh et al (2013) reported on a case series study that explored the safety, tolerability, and early efficacy of the TX1 device in the treatment of recalcitrant lateral elbow tendinopathy. Twenty patients (7 male and 13 female aged 33 to 65 years) who failed nonoperative therapy underwent the ultrasonic microresection procedure using the TX1 device through a stab incision under local anesthesia. Outcome parameters included patient satisfaction, visual analog scale (VAS) pain scores, Disabilities of the Arm, Shoulder and Hand (DASH) scores at 1, 3, 6 and 12 months, and ultrasound assessment at 3 and 6 months. A significant improvement in VAS score (from 5.5 to 3.3) occurred by 1 week. Significant improvements in both DASH-Compulsory (from 21.7 to 11.3) and DASH-Work (from 25.0 to 6.3) scores occurred by 1 month. The VAS scores further improved at 3, 6, and 12 months (from 2.0 to 1.0 to 0.50) and the DASH-Compulsory score improved significantly from 3 to 6 months (from 8.6 to 4.6). Both the DASH-Compulsory and DASH-Work scores were sustained by 12 months. Sonographically reduced tendon thickness (n=19), resolved or reduced hypervascularity (n=patients), and reduced hypoechoic area (n=18) occurred by 6 months. Nineteen of the 20 patients (95%) expressed satisfaction (either very or somewhat) with the procedure, with 9 patients being very satisfied with their overall experience at 6 months after the procedure and 1 patient neutral. The authors concluded that ultrasonic microresection of diseased tissue with the TX1 device provides a focally directed, safe, specific, minimally invasive, and well-tolerated treatment for recalcitrant lateral elbow tendinopathy in an office-based or ambulatory surgical setting with good evidence of some level of efficacy in 19 of 20 patients (95%) that is sustained for at least 1 year. The limitations of this study are that it involved a small number of subjects, was uncontrolled and follow-up was short term (12 months).
Barnes et al (2015) prospectively studied 19 patients (aged 38 to 67) with medial (n=7) or lateral (n=12) elbow tendinopathy who had failed conservative management. All patients were treated with percutaneous ultrasonic tenotomy of the elbow using the TX1 device by a single operator. Visual analog scale (VAS) for pain, the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) index, and the Mayo Elbow Performance Score (MEPS) were assessed before treatment and after treatment (6 weeks, 3 months, 6 months, and 12 months). Average VAS scores were significantly improved from 6.4 to 2.6 at 6 weeks and were 0.7 at 12 months. Similar improvement occurred with the Quick DASH (pretreatment, 44.1; 12 months, 8.6) and MEPS (pretreatment, 59.1; 12 months, 83.4). The authors concluded that sonographically guided percutaneous ultrasonic tenotomy and debridement using the TX1 device appears to be a safe treatment option for patients presenting with chronic, refractory lateral or medial elbow tendinopathy and provides significant and sustainable improvements in pain and function during a 1-year follow-up period. However, the authors acknowledged several study limitations including a small number of subjects, no control group, and lack of insight regarding the therapeutic mechanism of the TX1 treatment. The authors also acknowledged that future prospective comparative studies are needed.
Elattrache and Morrey (2013) published an article on percutaneous ultrasonic tenotomy as a treatment for chronic patellar tendinopathy which is commonly called Jumper’s knee. Based on early two-year results, the authors concluded that the procedure appears to be a safe and effective treatment with rapid recovery for Jumper’s knee.
SUMMARY OF EVIDENCE
For individuals with plantar fasciitis who receive RF coblation tenotomy, the evidence includes nonrandomized, comparative cohort studies and case series. The relevant outcomes are symptoms, functional outcomes, quality of life (QOL), medication use, and treatment-related morbidity. The trials reported improved pain and functional scores over 3-12 months, with improved outcomes with open vs percutaneous approaches. However, open RF coblation microtenotomy was associated with a higher incidence of postoperative persistent pain (9.1%) compared to endoscopic plantar fasciotomy (0%) in one study, with a separate study reporting a complication rate of 33% when both interventions were used
in combination. A higher number of postoperative pain recurrences at 6 and 12 months were also reported with open RF coblation microtenotomy compared to endoscopic plantar fasciotomy. The durability of this intervention is unknown as no studies have reported long-term outcomes beyond 12 months. Studies are limited by small sample sizes, heterogeneity in surgical technique (open, percutaneous, endoscopic), missing data and/or inappropriate exclusions, lack of randomization, unclear blinding practices for patient outcome assessments, and poor statistical reporting. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with lateral epicondylitis who receive RF coblation tenotomy, the evidence includes small randomized controlled trials (RCTs). The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trials compared RF microtenotomy to open or arthroscopic elbow release surgery. Clinically meaningful improvements in pain and functional scores were noted for all treatment arms, with no significant differences between groups through one to seven years of follow-up. For disability assessments in one study, open release surgery met the threshold for a clinically meaningful improvement over RF microtenotomy at one year, though this mean difference was not statistically significant. Studies were generally underpowered or demonstrated inconsistent delivery and unclear blinding of outcome assessments and inappropriate handling of missing or crossover data. No studies featuring RF coblation tenotomy for the treatment of wrist tendinopathy were identified. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with Achilles tendinopathy who receive RF coblation tenotomy, the evidence includes a small, single-blinded RCT. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trial did not demonstrate an added benefit for RF microdebridement compared to surgical decompression. Pain and functional outcomes improved in both groups but were not statistically different at a six month follow-up. The study was limited by a control group that showed significantly less severe symptom scores at baseline that did not fully meet the two point threshold for a clinically meaningful difference in pain score reduction. Larger, adequately controlled
studies with longer follow-up durations are lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with shoulder or rotator cuff tendinopathy who receive RF coblation tenotomy, the evidence includes small RCTs. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Trials did not demonstrate an added benefit for RF microdebridement compared to arthroscopic subacromial decompression surgery. Pain and functional outcomes improved in both groups but were not statistically different through one to two years follow-up. Neither study prespecified a clinically meaningful difference in outcome measures nor were harms assessed throughout their course. The loss to follow-up in 1 study was 18.7%. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with patellar tendinopathy who receive radiofrequency coblation tenotomy, the evidence includes one small RCT. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trial did not demonstrate an added benefit for RF microdebridement compared to mechanical debridement in patients with chondral lesions and patellar tendinopathy. The study lacked reporting with validated pain measures over time and reported a higher incidence of crepitus in patients undergoing RF microdebridement. Furthermore, the study only enrolled female participants, limiting the broader applicability of these findings. Larger studies with validated pain
and functional outcome measures are required to adequately assess the technology. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with musculoskeletal conditions who receive ultrasonic ablation, there is currently a lack of evidence in the peer-reviewed medical literature in the form of randomized, double-blind controlled trials demonstrating the efficacy and safety of percutaneous ultrasonic ablation of soft tissue using minimally invasive devices for the treatment of any condition, including, but not limited to chronic conditions of the musculoskeletal system (for example, fasciopathy or tendinopathy). While short-term results from a limited number of small case series report early positive outcomes in reduction of pain and improvement in physical function, further investigation is needed to determine if percutaneous ultrasonic ablation with devices such as the TX1 Tissue Removal System or Tenex Health TX System can sustain functional improvement and eliminate or reduce pain in individuals with chronic or recalcitrant conditions of the soft tissue. Well-designed prospective, randomized controlled trials comparing percutaneous ultrasonic ablation to standard treatments are needed to determine if spontaneous improvement without the procedure can be excluded and if a durable treatment effect can be established over placebo.
PRACTICE GUIDELINES AND POSITION STATEMENTS
American College of Foot and Ankle Surgeons
The American College of Foot and Ankle Surgeons (2017) published a clinical consensus statement on the diagnosis and treatment of adult acquired infracalcaneal heel pain based upon the best available evidence in the literature (Schneider et al, 2017). The panel determined that the following statement was uncertain – that is – neither appropriate nor inappropriate:
“Other surgical techniques (eg, ultrasonic debridement using a microtip device, cryosurgery, and bipolar radiofrequency ablation) are safe and effective options for chronic, refractory plantar
fasciitis.”
American College of Occupational and Environmental Medicine
The American College of Occupational and Environmental Medicine (2006) updated their treatment guidelines for lateral epicondylitis as a result of a systematic review of the literature (Hegmann et al, 2013). Surgery is recommended for cases inadequately responsive to multiple evidence-based treatments (Level of Evidence: I, insufficient evidence). Microtenotomy is also recommended (Level of Evidence: C, limited evidence base).
U.S. Preventive Services Task Force Recommendations
No U.S. Preventive Services Task Force recommendations for the use of radiofrequency coblation tenotomy have been identified.
Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed below.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 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 January 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Al-Ani et al conducted a single-blind RCT evaluating RF microtenotomy compared to physical therapy for individuals with Achilles tendinopathy of at least 6 months in duration that was impairing daily and sports activities (Al-Ani, 2021). The primary outcome measure was VAS at 2 years, with a difference of 2 units considered a clinically important difference. The control group had significantly less severe symptoms as indicated by lower VAS scores at baseline. The RF microtenotomy group demonstrated significantly greater improvements in both the VAS and Foot and Ankle Outcome Score (FAOS) Quality of Life measures at 2 years. However, conclusions cannot be drawn based on these findings due to numerous and notable study relevance and design/conduct limitations.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Nayar et al completed a systematic review of surgical treatment options for plantar fasciitis including open plantar fasciotomy, endoscopic plantar fasciotomy, gastrocnemius release, RF microtenotomy, and dry needling (Nayar, 2023). A total of 17 studies (8 RCTs, 3 prospective cohort, and 6 retrospective cohort) with 865 patients were selected for inclusion. Radiofrequency microtenotomy was investigated in 4 studies (n=215), all of which were retrospective cohort studies. Two studies compared RF microtenotomy to open plantar fasciotomy, 1 to edoscopic plantar fasciotomy, and 1 to proximal medial gastrocnemius release. The 2 studies comparing RF microtenetomy and plantar fasciotomy found no difference between groups in VAS and AOFAS outcomes. Similarly, the other studies found no difference in pain or function between groups. In network meta-analysis, RF microtenotomy significantly improved VAS compared with nonoperative management (weighted mean difference, -2.72; 95% CI, -4.84 to -0.060). No other significant difference between RF microtenotomy and other surgical interventions was found (mean differences not reported). The analysis is limited by the lack of high-quality studies. Studies included were largely observational, and at some risk of bias.
Yuan et al retrospectively compared open plantar fasciotomy to RF microtenotomy in 31 patients with plantar fasciitis (Yuan, 2020). Although operative time (19.93 minutes vs. 36.78 minutes) and recovery time (13.27 days vs. 25.94 days) were shorter with RF microtenotomy, there were no differences in VAS scores or AOFAS score between the treatments.
Huang et al reviewed all patients with plantar fasciitis (N=34) who underwent RF microtenotomy (TOPAZ device) with or without a gastrocnemius recession from 2007 to 2014 at a single institution (Huang, 2018). The AOFAS hindfoot score scale (total score [HINDTOT], VAS pain score [HINDVAS]) and the patient-reported SF-36 were administrated pre-operatively and at 3, 6, and 12 months post-operatively. There were no significant differences in HINDTOT or HINDVAS between groups at any of the measured timepoints. Components of SF-36 scores were also similar between individual treatments, but some components were improved with combination treatment compared with either RF microtenotomy or gastrocnemius recession alone.
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U.S. FDA(2013) 510(k) approval for the TX1 Tissue Removal System (K123640). March 20, 2013. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K123640.pdf Wang W, Rikhraj IS, Chou ACC et al(2017) Endoscopic Plantar Fasciotomy vs Open Radiofrequency Microtenotomy for Recalcitrant Plantar Fasciitis Foot Ankle Int, 2017 Nov 29;39(1) PMID 29182482 Weil L, Glover JP, Weil LS(2008) A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis Foot Ankle Spec, 2008 Feb 1;1(1) PMID 19825686 Williams RC, Pourcho AM.(2017) Percutaneous Ultrasonic Tenotomy for Refractory Common Extensor Tendinopathy After Failed Open Surgical Release: A Report of Two Cases. PM R : the journal of injury, function, and rehabilitation. 2017 Aug 5. 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