Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy

NCT06342245 | Not Yet Recruiting

• 1 other identifier: 2023.568
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  2weeks, 4 weeks, 2 months, 3 months, 6 months, 1 yesr after sugery

Study Arms (2)

radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement

EXPERIMENTAL

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

endoscopic Achilles debridement only

NO INTERVENTION

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.

Interventions

Radiofrequency coblation micro-tenotomy RADIATION

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.

radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Central Study Contacts

Samuel Ling

CONTACT

+852 3505 2010; samuel.ling@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: This is a multicentre 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). Investigators will obtain written consent from all participants before the commencement of this study.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: June 11, 2024
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): June 11, 2027
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share