PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

Study 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 CE-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, multicentre, 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. 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. All subjects treated with the AchilloCordPLUS for acute Achilles tendon repair will be consecutively recruited into the study.

Official Title
-----------------
Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

Conditions
-----------------
Achilles Tendon Rupture

Intervention / Treatment
-----------------
* Device: AchilloCordPLUS™ System Implant


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AchilloCordPLUS<br>End to end repair for acute Achilles tendon rupture with AchilloCordPLUS | Device: AchilloCordPLUS™ System Implant<br>* AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achilles Tendon Rupture Score (ATRS) | Change in ATRS Score 0-100 0=major limitations 100=no limitations | 6 months | 
| adverse events (AE) | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achilles Tendon Rupture Score (ATRS) | Change ATRS Score from baseline upto 2 years in 0-100 0=major limitations 100=no limitations | 2 years | 
| Length of time to unaided full weight bearing | Length of time to defined as removal of heel raise and walking unaided | 2 years | 
| return to work and return to sport. | Time for patients to return to work and return to sport. | 2 years | 
| Tegner Activity Scale | 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) | 2 years | 
| RAND Short Form 36 (SF 36) V1 | Change from RAND SF 36 Patient-reported quality of life 0-100 a higher sore indicates a higher health state | 2 years | 
| Tegner Activity Scale | Change from Tegner score from baseline to 2 years 10 (competitive sport) 0 (sick leave or disability pension) | 2 years | 
| Range of Motion | Change in ROM (ankle dorsi and plantar flexion) between each time point up to 6 months after surgery and compare to the contralateral side. | 6 months | 
| Calf Circumference | Change in calf circumference from 6 weeks up to 6 months and compare to the contralateral side. | 6 months | 
| Adverse Event | 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). | 2 years |