Degenerative Achilles Tendon Rupture Repair With Regeneten Augmentation

NCT ID: NCT06252389

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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)

Conditions

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Achilles Tendon Rupture Achilles Tendinopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Achilles Regeneten

bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy

Achilles Tendon Repair augmented with Bioinductive Collagen Patch

Intervention Type PROCEDURE

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

Interventions

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Achilles Tendon Repair augmented with Bioinductive Collagen Patch

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Samuel KK Ling

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Hong Kong, SAR, Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Samuel Ling, MBChB

Role: CONTACT

+852 35052010

Other Identifiers

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AchillesRegeneten

Identifier Type: -

Identifier Source: org_study_id

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