Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction

Condition(s) studied

Investigational drug(s) / intervention(s)

Poly-Tape Devices: Poly-Tape Devices, 10mm Poly-Tape or 5mm Infinity-Lock Tape, for Medial Patellofemoral Ligament (MPFL) Reconstruction

Study 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 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 tendons. 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 59 subjects will be enrolled into the study with follow up at 6 weeks, 6 months, 1 year, 2 years and 5 years in clinic and by questionnaires. All subjects treated with either the 10mm Poly-Tape or 5mm Infinity-Lock Tape for MPFL reconstruction, will be consecutively recruited into the study.

Eligibility

Primary outcome measure(s)

• Kujala Score — 1 year
  The primary performance objective is to determine the effect of MPFL reconstruction on symptoms and functional limitations 1 year after surgery, measured using the Kujala .Total score. Total scores range from 0 to 100 with high scores indicating good
• Redislocation/subluxation events — 1 year
  The primary safety objective is to assess redislocation/subluxation events at 1 year after surgery

Trial sites (5)