An interventional study of Radiofrequency coblation micro-tenotomy in Achilles Tendinopathy, sponsored by Chinese University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
Radiation: Radiofrequency coblation micro-tenotomy
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.
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.
Victorian Institute of Sports Assessment
The primary outcome measure will be the Victorian Institute of Sports Assessment - Achilles (VISA-A) questionnaire, either the original English version or the validated Chinese version, depending on the participant's native tongue.
Time frame: 2weeks, 4 weeks, 2 months, 3 months, 6 months, 1 yesr after sugery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong