MedPath

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

Recruiting
Conditions
Medial Patellofemoral Dislocation
Registration Number
NCT05264389
Lead Sponsor
Xiros Ltd
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
55
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Kujala Score1 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 events1 year

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

Secondary Outcome Measures
NameTimeMethod
Patient-reported quality of life (RANDShort form 36)5 years

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

Full range of motion (ROM)5 years

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)

Norwich Patellar Instability (NPI) score5 years

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

Patient satisfaction with Surgery5 years

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

Patient-reported activity levels5 years

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

Adverse events, including re-dislocation/subluxation5 years

Secondary safety objectives include: Adverse events, including

Trial Locations

Locations (4)

James Paget University Hospitals NHS Foundation Trust

🇬🇧

Great Yarmouth, United Kingdom

University of North Midlands NHS Trust

🇬🇧

Stoke-on-Trent, United Kingdom

Hampshire Hospitals NHS Foundation Trust

🇬🇧

Winchester, United Kingdom

Somerset NHS Foundation Trust

🇬🇧

Yeovil, United Kingdom

James Paget University Hospitals NHS Foundation Trust
🇬🇧Great Yarmouth, United Kingdom

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.