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

Last updated: January 29, 2025
Sponsor: Xiros Ltd
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

AchilloCordPLUS™ System Implant

Clinical Study ID

NCT05304819
CRE 029
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 natureof the study, agree to its follow-up and has provided written informed consent asapproved by the Research Ethics Committee (REC).

Exclusion

Exclusion Criteria:

  • Patients with chronic ruptures of the Achilles tendon.

  • Patients with bilateral ruptures.

  • Patients with known hypersensitivity to implant materials. Appropriate tests shouldbe carried out on patients with suspected material sensitivity prior toimplantation.

  • Patients with infections or any structural or pathological condition of the bone orsoft tissue that would be expected to impair healing or prevent secure fixation.

  • Patients who are unable or unwilling to restrict activities to prescribed levels orto follow the rehabilitation instructions during the healing period.

Study Design

Total Participants: 19
Treatment Group(s): 1
Primary Treatment: AchilloCordPLUS™ System Implant
Phase:
Study Start date:
March 09, 2022
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • North Cumbria Integrated Care Nhs Foundation Trust

    Penrith, CA11 7BF
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.