BioPoly® RS Partial Resurfacing Patella Registry Study

Study Overview
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Brief Summary
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The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring of the clinical safety and performance of the device and surgical implantation kit

Detailed Description
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The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant This study will also allow monitoring of the clinical safety and performance of the device and surgical implantation kit

Official Title
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Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant

Conditions
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Cartilage Disease

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 years and older Cartilage lesion(s) located in the facets of the patella that have failed prior therapy (conservative or surgical) Symptomatic lesions classified as ICRS grade 2, 3, or 4 Lesion size may not exceed 3.1 cm2 and must be circumscribed by a 15 mm or 20 mm circle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall depth less than 4 mm from the articulating surface Subchondral bone quality sufficient to support the implant Understanding and willingness to comply with the post-operative rehabilitation instructions and follow-up visits. Exclusion Criteria: Body mass index (BMI) ≥ 35 Generalized degenerative or autoimmune arthritis Gout Uncorrected chronic malalignment of the patella (may be corrected at the same time as the implantation of the BioPoly device). Uncorrected ligamentous instability (may be corrected at the same time as the implantation of the BioPoly device). Kissing lesion on femur More than one implant required to accommodate lesion Allergy to ultra-high molecular weight polyethylene (UHMWPE), or hyaluronan/ hyaluronic acid (HA) Use with opposing articulating femoral components Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee Pregnant, prisoner, vulnerable population, or unable to provide informed consent.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BioPoly RS Partial Resurfacing Patella Implant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Subscores | KOOS | 2 year post-op | 
| Kujala Anterior Knee Pain Scale | Kujala | 2 year post-op | 
| Medical Outcomes Study (SF-36) for generic quality of life | SF-36 | 2 years post-op | 
| Activity using Tegner Score | Tegner | 2 years post-op | 
| Pain using VAS Pain | VAS Pain | 2 years post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Assessment | Radiographic Assessment | Annually through 5 years post-op | 

 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