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NCT06252389 Clinical Trial

Degenerative Achilles Tendon Rupture Repair With Regeneten Augmentation

Achilles Tendinopathy Clinical Trial

Official title:
Treating Achilles Tendon Rupture Complicated by Pre-existing Tendinopathy With Repair Augmented With a Bioinductive Collagen Implant

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06252389
Other study ID # AchillesRegeneten
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2025
Est. completion date March 2025

Study information
Verified date February 2024
Source Chinese University of Hong Kong
Contact Samuel Ling, MBChB
Phone +852 35052010
Email samuel.ling@link.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective Case Series to investigate the effect a bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy

Description:

Retrospective Case Series. Investigate the effect a bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy. Acute Achilles tendon rupture patients all underwent pre-operative ultrasound; those with tendinopathy enrolled into study. Standard Achilles tendon repair performed; augmented with a bioinductive collagen patch (Regeneten)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 9
Est. completion date March 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pre-operative ultrasound confirmation of tendinopathy Exclusion Criteria: - Underwent lower limb intervention with past 3 months - Physical or psychological condition impairing ability to consent - Physical or psychological condition impairing ability to adhere to rehabilitation protocol - allergy to bovine material - pregnant individuals

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Achilles Tendon Repair augmented with Bioinductive Collagen Patch
Standard Achilles Tendon Repair augmented with Bioinductive Collagen Patch. Standard Rehabilitation Protocol.

Locations
Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong SAR

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Foot and Ankle Outcome Score (FAOS) Symptoms measured by the patient reported outcome measure FAOS. It is split into 5 sections including: Symptoms, Pain, ADL function, Sporting activity, and Quality of Life. 2 weeks, 6 weeks, 3 months, 6 months
Secondary Victoria Institute of Sports Assessment - Achilles (VISA-A) Symptoms measured by the Achilles specific patient reported outcome measure VISA-A. 2 weeks, 6 weeks, 3 months, 6 months
See also
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Recruiting NCT04663542 - The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery N/A
Withdrawn NCT04492059 - Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture N/A
Recruiting NCT03259204 - Swedish Multicenter Trial of Outpatient Prevention of Leg Clots N/A
Completed NCT02805751 - Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures N/A
Completed NCT00489749 - A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture N/A
Active, not recruiting NCT03525964 - Individualized Treatment of Acute Achilles Tendon Rupture N/A
Completed NCT02018224 - Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up. N/A
Completed NCT04121377 - Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture N/A
Active, not recruiting NCT02318472 - Early Mobilization After Achilles Tendon Rupture N/A
Terminated NCT01237613 - Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon N/A
Recruiting NCT06254794 - Effect of BFR Rehab After Achilles Tendon Rupture N/A
Recruiting NCT06009978 - Effect of Additional Treatment With NMES After Achilles Tendon Rupture N/A
Enrolling by invitation NCT05614908 - Outcome After Conservatively Treated Achilles Tendon Rupture
Completed NCT03931486 - Detection of Bacterial DNA and Collagen Metabolism in Acutely Ruptured Achilles Tendons
Recruiting NCT05683080 - Impact of Achilles Tendon Rupture on the Achilles Tendon and Calf Muscles
Recruiting NCT05717270 - Two-layer Suturing of Achilles Tendon Ruptures
Completed NCT04263493 - Delayed Loading Following Repair of a Ruptured Achilles Tendon N/A
Not yet recruiting NCT05676632 - Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis
Recruiting NCT04912154 - The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery N/A