Status:
ACTIVE_NOT_RECRUITING
PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
Lead Sponsor:
Xiros Ltd
Conditions:
Achilles Tendon Rupture
Eligibility:
All Genders
18+ years
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 repai...
Detailed 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 repai...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05304819
Start Date
March 9 2022
End Date
January 1 2026
Last Update
January 31 2025
Active Locations (1)
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1
North Cumbria Integrated Care Nhs Foundation Trust
Penrith, United Kingdom, CA11 7BF