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

Study Overview
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Brief Summary
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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.

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

Conditions
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Medial Patellofemoral Dislocation

Intervention / Treatment
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* Device: Poly-Tape


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Poly-Tape Device<br>Poly-Tape Device for Medial Patellofemoral Ligament (MPFL) Reconstruction | Device: Poly-Tape<br>* Poly-Tape Device for Medial Patellofemoral Ligament (MPFL) Reconstruction<br>|

What is the study measuring?
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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 |