Medial Patellofemoral Dislocation Clinical Trial
Official title:
Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Device for Medial Patellofemoral Ligament (MPFL) Reconstruction
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 Device in this study, Poly-Tape, is a Class IIb CE-Marked device manufactured by Xiros Ltd. Poly-tapes are a single-use device, they are indicated for patients repair of soft tissue and/or reconstruction of ligaments, tendons, and other soft tissues. The device can be fixed to the bone using several different methods including screws. This study is a prospective, multicentre, consecutively recruited non-randomised study. The total length of the study is expected to be 7 years. This includes a recruitment period of approximately 24 months and a 5-year follow-up. A total of 55 subjects will be enrolled into the study with follow up at 6 months, 1 year, 2 years and 5 years in clinic and by questionnaires. All subjects treated with the Poly-Tape for MPFL reconstruction, will be consecutively recruited into the study.
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