Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy (AT RCT)

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Achilles Tendinopathy

Treatments: Radiation: Radiofrequency coblation micro-tenotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06342245

2023.568

Details and patient eligibility

About

This is a prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only). Adults (age >18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist / athletic trainer. Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention. Criteria for discontinuing or modifying allocated interventions, Strategies to improve adherence to interventions, Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care. Outocme measure will use VISA-A, pain scores, ultrasound measurement of thickness and vascularity, calf muscle strength, and ankle range of motion.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The inclusion is ultrasound-confirmed Achilles tendinopathy. Adults (age >18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. Ultrasonography diagnostic criteria include a thickened Achilles tendon and a Colour Doppler of at least 1 out of 3 in the Öhberg score 2-6 cm proximal to the Achilles tendon insertion. Victorian Institute of Sports Assessment -Achilles (VISA-A) scores below 60 points.

Exclusion criteria

• Patients will be excluded if they had a history of major injury or surgery on the affected lower limb in the past year and have mental/physical limitations hindering the participant's ability to complete assessments (ankle arthritis, neuromuscular disorders, etc.), including severe cognitive impairment and psychiatric disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement

Experimental group

Description:

The patient will lie prone on the surgical table, and the area of tendinopathy will be visualized with endoscopy. Endoscopic-assisted creation of a percutaneous mesh (quincunx) pattern of 1mm skin incisions will be made over the area of tendinopathy with a 5mm distance between each incision. Radiofrequency micro-tenotomy with low-temperature controlled ablation will be performed with the TOPAZ (Smith and Nephew) wand, which has a 1mm tip, and full thickness 1mm RF tendon debridement at 5mm intervals will be performed. Incisions will be fixed with sterile strips

Treatment:

Radiation: Radiofrequency coblation micro-tenotomy

endoscopic Achilles debridement only

No Intervention group

Description:

Minimally invasive and endoscopic procedures yield lower complication rates with similar patient satisfaction compared to open procedures. Minimally invasive and endoscopic procedures were recommended as the future surgical treatment of Achilles midportion tendinopathy. Both the control and the intervention group will undergo endoscopic Achilles tendon debridement. The procedure will be performed in the operating theatre under general or regional anesthesia. The patient will lie prone on the operating table, and the leg will be prepared and draped under sterile technique. Two co-axial 0.5cm endoscopic portals will be created as per standard protocol, and a 4mm scope will be introduced for visualization.