Long-term safety and performance evaluation of the Poly-Tape device for knee ligament reconstruction
Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Device for Medial Patellofemoral Ligament (MPFL) Reconstruction
This study is testing how safe and effective the Poly-Tape device is for people who have had knee ligament reconstruction to fix dislocations over a long period of time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | Xiros Ltd Industry-sponsored |
| Locations | 3 sites (Stoke-on-Trent and 2 other locations) |
| Trial ID | NCT05264389 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term safety and performance of the Poly-Tape device used for medial patellofemoral ligament (MPFL) reconstruction in patients with medial patellofemoral dislocation. The study will enroll 55 subjects over a 24-month recruitment period, followed by a 5-year follow-up, during which participants will be monitored through clinic visits and questionnaires. The Poly-Tape device is a single-use, CE-marked medical device designed for soft tissue repair and ligament reconstruction, and its effectiveness will be evaluated in a multicenter setting.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 13 years and older who require MPFL reconstruction.
Not a fit: Patients with immature growth plates, known hypersensitivity to titanium alloy or polyester, or those with infections or conditions impairing healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the Poly-Tape device, potentially improving treatment options for patients with knee ligament injuries.
How similar studies have performed: While this study focuses on a specific device, similar studies evaluating the safety and performance of orthopedic devices have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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.
Where this trial is running
Stoke-on-Trent and 2 other locations
- University of North Midlands NHS Trust — Stoke-on-Trent, United Kingdom (Recruiting)
- Hampshire Hospitals NHS Foundation Trust — Winchester, United Kingdom (Recruiting)
- Somerset NHS Foundation Trust — Yeovil, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Vikki Adams
- Email: vikki.adams@xiros.co.uk
- Phone: 07825626018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.