Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices 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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Medial Patellofemoral Dislocation
• Intervention / Treatment: Device: Poly-Tape Devices

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United Kingdom
  • Great Yarmouth, United Kingdom, NR31 6LA
    • James Paget University Hospitals NHS Foundation Trust
  • Manchester, United Kingdom, OL6 9RW
    • Tameside and Glossop Integrated Care NHS Foundation Trust
  • Stoke-on-Trent, United Kingdom
    • University of North Midlands NHS Trust
  • Winchester, United Kingdom, SO22 5DG
    • Hampshire Hospitals NHS Foundation Trust
  • Yeovil, United Kingdom, BA21 4AT
    • Somerset NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who require MPFL reconstruction.

Description

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Poly-Tape Devices; Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction	Device: Poly-Tape Devices; Poly-Tape Devices, 10mm Poly-Tape or 5mm Infinity-Lock Tape, for Medial Patellofemoral Ligament (MPFL) Reconstruction; Other Names: 10mm Poly-Tape; 5mm Infinity-Lock Tape

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full range of motion (ROM)	Secondary performance objectives are to determine the effect of MPFL reconstruction on the following during the performance lifetime of the device: Full range of motion (ROM)	5 years
Norwich Patellar Instability (NPI) score	Change from baseline Norwich Patellar Instability (NPI) score at each visit up to 1 year. The score is made up of 0 to 250. Out of the total score-able answers, where "don't do" answered questions are deducted, the total score is then converted as a percentage based on the number of scored responses provided. A higher percentage indicate higher severity of patellar instability	5 years
Patient-reported quality of life (RANDShort form 36)	Secondary performance objectives are to determine the effect of MPFL reconstruction on the following during the performance lifetime of the device: Patient-reported quality of life 0-100 a higher sore indicates a higher health state	5 years
Patient-reported activity levels	Secondary performance objectives are to determine the effect of MPFL reconstruction on the following during the performance lifetime of the device: Patient-reported activity levels 0-10 , 10 is a high level of activity	5 years
Patient satisfaction with Surgery	Secondary performance objectives are to determine the effect of MPFL reconstruction on the following during the performance lifetime of the device: Patient satisfaction with Surgery. Yes or No	5 years
Adverse events, including re-dislocation/subluxation	Secondary safety objectives include: Adverse events, including	5 years

Collaborators and Investigators

• Sponsor: Xiros Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): May 7, 2026
• Study Completion (Estimated): August 4, 2031

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations
• Other Study ID Numbers: CRE 022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No