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

NCT05264389 | Recruiting

• 1 other identifier: CRE 022
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 5

Brief 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 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 either the 10mm Poly-Tape or 5mm Infinity-Lock Tape for MPFL reconstruction, will be consecutively recruited into the study.

Conditions

Medial Patellofemoral Dislocation

Outcome Measures

Primary Outcomes (2)

• Kujala Score

  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

  1 year

• Redislocation/subluxation events

  The primary safety objective is to assess redislocation/subluxation events at 1 year after surgery

  1 year

Secondary Outcomes (6)

• Full range of motion (ROM)

  5 years

• Norwich Patellar Instability (NPI) score

  5 years

• Patient-reported quality of life (RANDShort form 36)

  5 years

• Patient-reported activity levels

  5 years

• Patient satisfaction with Surgery

  5 years

Study Arms (1)

Poly-Tape Devices

Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction

Device: Poly-Tape Devices

Interventions

Poly-Tape Devices DEVICE

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

Also known as: 10mm Poly-Tape, 5mm Infinity-Lock Tape

Poly-Tape Devices

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who require MPFL reconstruction.

You may qualify if:

• Patient must be 13 years old or above. Patients who require MPFL reconstruction. Patients willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC).

You may not qualify if:

• These devices should not be used in procedures which bridge, disturb, or disrupt the growth plate in immature patients since they will not elongate as the patient grows.
• Patients known to be hypersensitive to titanium alloy or polyester. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.
• Patients with any infections or structural or pathological condition of the bone or soft tissue that would be expected to impair healing or secure fixation. Bone quality should be assessed prior to surgery.
• Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.
• Patients for whom the implantation is intended to be non-permanent, since they integrate well with the patient's tissue.

Sponsors & Collaborators

• Xiros Ltd: lead

Study Sites (5)

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, NR31 6LA, United Kingdom

RECRUITING

Tameside and Glossop Integrated Care NHS Foundation Trust

Manchester, OL6 9RW, United Kingdom

RECRUITING

University of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

RECRUITING

Hampshire Hospitals NHS Foundation Trust

Winchester, SO22 5DG, United Kingdom

RECRUITING

Somerset NHS Foundation Trust

Yeovil, BA21 4AT, United Kingdom

RECRUITING

Central Study Contacts

Lisa Cook

CONTACT

+44 (0) 113 238 7200; lisa.cook@xiros.co.uk

Vikki Adams

CONTACT

07825626018; vikki.adams@xiros.co.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 3, 2022
• Study Start: September 5, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2031
• Last Updated: January 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)