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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-09

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Achilles Tendon Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AchilloCordPLUS

End to end repair for acute Achilles tendon rupture with AchilloCordPLUS

AchilloCordPLUS™ System Implant

Intervention Type DEVICE

AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

Interventions

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AchilloCordPLUS™ System Implant

AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No