Degenerative Achilles Tendon Rupture Repair With Regeneten Augmentation

February 1, 2024 updated by: Samuel KK Ling, Chinese University of Hong Kong

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • SAR
      • Hong Kong, SAR, Hong Kong, HK
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All individuals admitted with an acute Achilles tendon rupture

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Achilles Regeneten
bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy
Procedure: Achilles Tendon Repair augmented with Bioinductive Collagen Patch
Standard Achilles Tendon Repair augmented with Bioinductive Collagen Patch. Standard Rehabilitation Protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot and Ankle Outcome Score (FAOS)
Time Frame: 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.
2 weeks, 6 weeks, 3 months, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Estimated)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AchillesRegeneten

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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