PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
- Conditions
- Achilles Tendon Rupture
- Interventions
- Device: AchilloCordPLUS™ System Implant
- Registration Number
- NCT05304819
- Lead Sponsor
- Xiros Ltd
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 19
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AchilloCordPLUS AchilloCordPLUS™ System Implant End to end repair for acute Achilles tendon rupture with AchilloCordPLUS
- Primary Outcome Measures
Name Time Method Achilles Tendon Rupture Score (ATRS) 6 months Change in ATRS Score 0-100 0=major limitations 100=no limitations
adverse events (AE) 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 Outcome Measures
Name Time Method RAND Short Form 36 (SF 36) V1 2 years Change from RAND SF 36 Patient-reported quality of life 0-100 a higher sore indicates a higher health state
Tegner Activity Scale (baseline) 2 years Change from Tegner score from baseline to 2 years 10 (competitive sport) 0 (sick leave or disability pension)
Achilles Tendon Rupture Score (ATRS) 2 years Change ATRS Score from baseline upto 2 years in 0-100 0=major limitations 100=no limitations
Length of time to unaided full weight bearing 2 years Length of time to defined as removal of heel raise and walking unaided
return to work and return to sport. 2 years Time for patients to return to work and return to sport.
Tegner Activity Scale (pre-injury) 2 years Number of patients who have returned to pre-injury levels of activity assessed using the Tegner Activity Scale 10 (competitive sport) 0 (sick leave or disability pension)
Range of Motion 6 months Change in ROM (ankle dorsi and plantar flexion) between each time point up to 6 months after surgery and compare to the contralateral side.
Calf Circumference 6 months Change in calf circumference from 6 weeks up to 6 months and compare to the contralateral side.
Adverse Event 2 years Adverse events up to 2 years 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, rerupture, DVT, wound infection and sural nerve damage).
Trial Locations
- Locations (1)
North Cumbria Integrated Care Nhs Foundation Trust
🇬🇧Penrith, United Kingdom