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.
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.
Study Type
OBSERVATIONAL
Enrollment
19
AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
North Cumbria Integrated Care Nhs Foundation Trust
Penrith, United Kingdom
Achilles Tendon Rupture Score (ATRS)
Change in ATRS Score 0-100 0=major limitations 100=no limitations
Time frame: 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).
Time frame: 6 months
Achilles Tendon Rupture Score (ATRS)
Change ATRS Score from baseline upto 2 years in 0-100 0=major limitations 100=no limitations
Time frame: 2 years
Length of time to unaided full weight bearing
Length of time to defined as removal of heel raise and walking unaided
Time frame: 2 years
return to work and return to sport.
Time for patients to return to work and return to sport.
Time frame: 2 years
Tegner Activity Scale (pre-injury)
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)
Time frame: 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
Time frame: 2 years
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Tegner Activity Scale (baseline)
Change from Tegner score from baseline to 2 years 10 (competitive sport) 0 (sick leave or disability pension)
Time frame: 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.
Time frame: 6 months
Calf Circumference
Change in calf circumference from 6 weeks up to 6 months and compare to the contralateral side.
Time frame: 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).
Time frame: 2 years