BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Cartilage Injury Defect of Articular Cartilage Cartilage Damage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BioPoly RS Implant

Group Type EXPERIMENTAL

BioPoly RS Partial Resurfacing Knee Implant

Intervention Type DEVICE

A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.

Interventions

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BioPoly RS Partial Resurfacing Knee Implant

A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.

Intervention Type DEVICE

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No