AchilloCordPLUS Post Market Follow Up Acute Achilles Tendon Repair
Research type
Research Study
Full title
Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
IRAS ID
301208
Contact name
Ashraf Naguib
Contact email
Sponsor organisation
Xiros Ltd
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a Post Market Clinical Follow Up Study. It will verify the long-term safety and performance of the AchilloCordPLUS when used for the acute repair of the Achilles tendon and used as described by the manufacturer’s instructions.
The Medical Device in this study, AchilloCordPLUS, is already on the market and is manufactured by Xiros Ltd.
The AchilloCordPLUS is a densely woven flexible tubular structure, 5 mm in diameter and 800 mm in length. Both ends of the device are flat, allowing it to be threaded easily through the eye of a blunt surgical needle, which is used to pull it through soft tissue and bone tunnels. It is particularly suited to active patients where an extended period of postoperative immobilisation is undesirable.
This study will collect data on patients who receive the device in the future; it will recruit patients from several sites and will recruit all patients at a site who receive the device and meet the entry criteria.
All patients who are entered into the study will receive the AchilloCordPLUS device, as it is a single armed study.
The total length of the study is expected to be 3 years. This includes a recruitment period of approximately 12 months and a 2-year follow-up.
A total of 55 subjects will be enrolled into the study.
Follow up is at 2, 4, 6, 8 and 12 weeks, 6 months and 1 and 2 years.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0175
Date of REC Opinion
24 Aug 2021
REC opinion
Further Information Favourable Opinion