BioPoly RS Knee Registry Study for Cartilage Defect Replacement

BioPoly

Status: Completed

Conditions: Cartilage Injury; Defect of Articular Cartilage; Cartilage Damage

Treatments: Device: BioPoly RS Partial Resurfacing Knee Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473199

1151001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

BioPoly RS Implant

Experimental group

Description:

BioPoly RS Implant

Treatment:

Device: BioPoly RS Partial Resurfacing Knee Implant