Achilles Tendon RuptureNCT06252389
Degenerative Achilles Tendon Rupture Repair With Regeneten Augmentation
An observational study of Achilles Tendon Rupture and Achilles Tendinopathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendon Rupture, Achilles Tendinopathy
- What is being tested?
- Achilles Tendon Repair augmented with Bioinductive Collagen Patch
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2025to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All individuals admitted with an acute Achilles tendon rupture
Who may be able to join
- Pre-operative ultrasound confirmation of tendinopathy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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)
- Conditions
- Achilles Tendon Rupture, Achilles Tendinopathy
- Being tested
- Achilles Tendon Repair augmented with Bioinductive Collagen Patch
- Keywords
- Achilles, Regeneten, Tendinopathy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achilles Tendon Repair augmented with Bioinductive Collagen PatchProcedure or surgery
Standard Achilles Tendon Repair augmented with Bioinductive Collagen Patch. Standard Rehabilitation Protocol.
| Study group | Role | What they receive |
|---|---|---|
| Achilles Regeneten | bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy Receives: Procedure: Achilles Tendon Repair augmented with Bioinductive Collagen Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks, 6 weeks, 3 months, 6 months
Secondary outcomes (1)
Victoria Institute of Sports Assessment - Achilles (VISA-A)
Symptoms measured by the Achilles specific patient reported outcome measure VISA-A.
Measured: 2 weeks, 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Feb 2025 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel KK Ling, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252389
- Sponsor's protocol ID
- AchillesRegeneten
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Achilles Tendon Rupture Complicated by Pre-existing Tendinopathy With Repair Augmented With a Bioinductive Collagen Implant
- ClinicalTrials.gov ID
- NCT06252389
- Acronym / sponsor ID
- AchillesRegeneten
- Conditions
- Achilles Tendon Rupture, Achilles Tendinopathy
- Keywords
- Achilles, Regeneten, Tendinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Achilles Regeneten | – | Procedure: Achilles Tendon Repair augmented with Bioinductive Collagen Patchbovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals admitted with an acute Achilles tendon rupture
Key inclusion criteria (1 listed)
- Pre-operative ultrasound confirmation of tendinopathy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Achilles Tendon Repair augmented with Bioinductive Collagen PatchStandard Achilles Tendon Repair augmented with Bioinductive Collagen Patch. Standard Rehabilitation Protocol. | Procedure or surgery | Achilles Regeneten |
Primary outcome
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.
1 secondary outcome
Victoria Institute of Sports Assessment - Achilles (VISA-A)
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon Rupture and Achilles Tendinopathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Ling, MBChB (+852 35052010, samuel.ling@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Outcome Score (FAOS) (time frame: 2 weeks, 6 weeks, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.