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

Achilles Tendon Rupture Clinical Trial

Official title:
Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

Clinical Trial 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05304819
Study type Observational
Source Xiros Ltd
Contact Charlotte Butterworth-Pool
Phone 01172180030
Email Charlotte.Butterworth-Pool@xiros.co.uk
Status Recruiting
Phase
Start date March 9, 2022
Completion date September 2026
View Details
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