Status:
RECRUITING
Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction
Lead Sponsor:
Xiros Ltd
Conditions:
Medial Patellofemoral Dislocation
Eligibility:
All Genders
13+ 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 reconstruct...
Eligibility Criteria
Inclusion
- Patient must be 13 years old or above. Patients who require MPFL reconstruction. Patients willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC).
Exclusion
- These devices should not be used in procedures which bridge, disturb, or disrupt the growth plate in immature patients since they will not elongate as the patient grows.
- Patients known to be hypersensitive to titanium alloy or polyester. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.
- Patients with any infections or structural or pathological condition of the bone or soft tissue that would be expected to impair healing or secure fixation. Bone quality should be assessed prior to surgery.
- Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.
- Patients for whom the implantation is intended to be non-permanent, since they integrate well with the patient's tissue.
Key Trial Info
Start Date :
September 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05264389
Start Date
September 5 2022
End Date
September 1 2031
Last Update
September 16 2025
Active Locations (5)
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1
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, United Kingdom, NR31 6LA
2
Tameside and Glossop Integrated Care NHS Foundation Trust
Manchester, United Kingdom, OL6 9RW
3
University of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
4
Hampshire Hospitals NHS Foundation Trust
Winchester, United Kingdom, SO22 5DG