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

Xiros

Status

Active, not recruiting

Conditions

Achilles Tendon Rupture

Treatments

Device: AchilloCordPLUS™ System Implant

Study type

Observational

Funder types

Industry

Identifiers

NCT05304819

CRE 029

Details and patient eligibility

About

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.

Full description

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.