Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
Overview
- Phase
- N/A
- Intervention
- AchilloCordPLUS™ System Implant
- Conditions
- Achilles Tendon Rupture
- Sponsor
- Xiros Ltd
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Achilles Tendon Rupture Score (ATRS)
- Status
- Completed
- Last Updated
- 11 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be skeletally mature and be 18 years old or above.
- •Patients requiring end to end repair for acute Achilles tendon rupture.
- •Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and has provided written informed consent as approved by the Research Ethics Committee (REC).
Exclusion Criteria
- •Patients with chronic ruptures of the Achilles tendon.
- •Patients with bilateral ruptures.
- •Patients with known hypersensitivity to implant materials. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.
- •Patients with infections or any structural or pathological condition of the bone or soft tissue that would be expected to impair healing or prevent secure fixation.
- •Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.
Arms & Interventions
AchilloCordPLUS
End to end repair for acute Achilles tendon rupture with AchilloCordPLUS
Intervention: AchilloCordPLUS™ System Implant
Outcomes
Primary Outcomes
Achilles Tendon Rupture Score (ATRS)
Time Frame: 6 months
Change in ATRS Score 0-100 0=major limitations 100=no limitations
adverse events (AE)
Time Frame: 6 months
Number of adverse events (AE) at 6 months after surgery which directly relate to the procedure that may have an effect on the patient's outcome (for example, irritation at the surgery site, re-rupture, deep-vein thrombosis (DVT), wound infection and sural nerve damage).
Secondary Outcomes
- Achilles Tendon Rupture Score (ATRS)(2 years)
- Length of time to unaided full weight bearing(2 years)
- return to work and return to sport.(2 years)
- Tegner Activity Scale (pre-injury)(2 years)
- RAND Short Form 36 (SF 36) V1(2 years)
- Tegner Activity Scale (baseline)(2 years)
- Range of Motion(6 months)
- Calf Circumference(6 months)
- Adverse Event(2 years)