- Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction — Active Not Recruiting • NCT05264389.
- Long-term safety study of Poly-Tape devices for kneecap ligament reconstruction surgery in 55 patients over five years.
Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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 reconstruction of a ligament in the kneecap - the Medial Patellofemoral Ligament (MPFL). The Medical Devices in this study, 10mm Poly-Tape and 5mm Infinity-Lock Tape, are Class III CE-Marked devices manufactured by Xiros Ltd. Both devices fall under the Poly-Tape family. Poly-Tapes are single-use devices, they are indicated for patients requiring soft tissue approximation and reconstruction of ligaments and…