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

NCT05264389 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2026-05-15

No results posted yet for this 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.

Conditions

  • Medial Patellofemoral Dislocation

Interventions

DEVICE

Poly-Tape Devices

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

Sponsors & Collaborators

  • Xiros Ltd

    lead INDUSTRY

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2026-05-07
Completion
2031-08-04

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264389 on ClinicalTrials.gov