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

X

Xiros

Status

Enrolling

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 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.

Enrollment

55 estimated 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.

Trial design

55 participants in 1 patient group

AchilloCordPLUS
Description:
End to end repair for acute Achilles tendon rupture with AchilloCordPLUS
Treatment:
Device: AchilloCordPLUS™ System Implant

Trial contacts and locations

1

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Central trial contact

Vikki Adams; Charlotte Butterworth-Pool

Data sourced from clinicaltrials.gov

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