CompletedNot Applicable

BioPoly RS Knee Registry Study for Cartilage Defect Replacement

United Kingdom38 participantsStarted 2011-11

Plain-language summary

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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Timeframe: 6 months

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Timeframe: 2 years

Trial details

NCT IDNCT01473199

SponsorBioPoly LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Cartilage Injury trials