Post Market Follow Up PolyTape MPFL
Research type
Research Study
Full title
Post Market Clinical Follow Up (PMCF) Study of the PolyTape device for Medial Patellofemoral Ligament (MPFL) Reconstruction
IRAS ID
292390
Contact name
Christopher Bailey
Contact email
Sponsor organisation
Xiros Ltd
Duration of Study in the UK
7 years, 0 months, 1 days
Research 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 Patellafemoral 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 Polytape for MPFL reconstruction, will be consecutively recruited into the study.REC name
North East - York Research Ethics Committee
REC reference
21/NE/0106
Date of REC Opinion
14 Jul 2021
REC opinion
Further Information Favourable Opinion