BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Study Overview
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Brief Summary
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Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.

Detailed Description
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Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device. Patients will be followed for 5 years after surgery.

Official Title
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Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant

Conditions
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Cartilage Injury, Defect of Articular Cartilage, Cartilage Damage

Intervention / Treatment
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* Device: BioPoly RS Partial Resurfacing Knee Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cartilage lesion located in weight bearing region of medial or lateral femoral condyles that have failed prior therapy (conservative or surgical) Lesion classified as ICRS Grade 2, 3, or 4 Exclusion Criteria: Body mass index (BMI) of 30 or more Osteoarthritis or rheumatoid arthritis Gout Uncorrected mal-alignment, ligamentous instability, or meniscal tear Total meniscectomy Kissing lesion on tibia

Ages Eligible for Study
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Minimum Age: 21 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioPoly RS Implant<br>BioPoly RS Implant | Device: BioPoly RS Partial Resurfacing Knee Implant<br>* A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | 6 months | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | Through 5 years | 
| VAS Pain | Visual analogue scale for assessment of pain | Through 5 years | 
| Tegner Activity | Measurement of patient's activity level | Through 5 years | 
| SF-36 | Assessment of patient's overall quality of life | Through 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focal defect, focal lesion, chondral lesion, osteochondral lesion