Degenerative Achilles Tendon Rupture Repair With Regeneten Augmentation

Not yet recruiting

• Conditions: Achilles Tendon Rupture; Achilles Tendinopathy
• Interventions: Procedure: Achilles Tendon Repair augmented with Bioinductive Collagen Patch

• Registration Number: NCT06252389
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed 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)

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Study Start: 2025-02-01
• Primary Completion: 2025-02
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Pre-operative ultrasound confirmation of tendinopathy

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Achilles Regeneten	Achilles Tendon Repair augmented with Bioinductive Collagen Patch	bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy

Primary Outcome Measures

Name	Time	Method
Foot and Ankle Outcome Score (FAOS)	2 weeks, 6 weeks, 3 months, 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Victoria Institute of Sports Assessment - Achilles (VISA-A)	2 weeks, 6 weeks, 3 months, 6 months	Symptoms measured by the Achilles specific patient reported outcome measure VISA-A.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, SAR, Hong Kong