Trials / Active Not Recruiting
Active Not RecruitingNCT05304819
PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 19 (actual)
- Sponsor
- Xiros Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Post Market Clinical Follow Up Study in Orthopaedics, it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the acute repair of the Achilles tendon. The Medical Device in this study AchilloCordPLUS is a Class IIb UKCA-Marked device manufactured by Xiros Ltd.
Detailed description
This is a Post Market Clinical Follow Up Study in Orthopaedics, it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the acute repair of the Achilles tendon. The Medical Device in this study AchilloCordPLUS is a Class IIb UKCA-Marked device manufactured by Xiros Ltd. AchilloCordPLUS is a single-use device, indicated for patients with acute Achilles tendon ruptures. It is particularly suited to active patients where an extended period of postoperative immobilisation is undesirable. This study is a prospective, single-centre, consecutively recruited non-randomised 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. This study has now closed to follow-up, with a recruitment of 19 participants. Follow up is at 2,4,6,8 and 12 weeks, 6 months and 1 and 2 years. All subjects treated with the AchilloCordPLUS for acute Achilles tendon repair will be consecutively recruited into the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AchilloCordPLUS™ System Implant | AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair |
Timeline
- Start date
- 2022-03-09
- Primary completion
- 2024-06-13
- Completion
- 2026-01-01
- First posted
- 2022-03-31
- Last updated
- 2025-01-31
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05304819. Inclusion in this directory is not an endorsement.