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

NCT05304819 | Completed

• 1 other identifier: CRE 029
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (2)

• Achilles Tendon Rupture Score (ATRS)

  Change in ATRS Score 0-100 0=major limitations 100=no limitations

  6 months

• adverse events (AE)

  Number of adverse events (AE) at 6 months after surgery which directly relate to the procedure that may have an effect on the patient's outcome (for example, irritation at the surgery site, re-rupture, deep-vein thrombosis (DVT), wound infection and sural nerve damage).

  6 months

Secondary Outcomes (9)

• Achilles Tendon Rupture Score (ATRS)

  2 years

• Length of time to unaided full weight bearing

  2 years

• return to work and return to sport.

  2 years

• Tegner Activity Scale (pre-injury)

  2 years

• RAND Short Form 36 (SF 36) V1

  2 years

Study Arms (1)

AchilloCordPLUS

End to end repair for acute Achilles tendon rupture with AchilloCordPLUS

Device: AchilloCordPLUS™ System Implant

Interventions

AchilloCordPLUS™ System Implant DEVICE

AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

AchilloCordPLUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring end to end repair for acute Achilles tendon rupture.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiros Ltd: lead

Study Sites (1)

North Cumbria Integrated Care Nhs Foundation Trust

Penrith, CA11 7BF, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: March 9, 2022
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)