BioPoly RS Knee Registry Study for Cartilage Defect Replacement

BioPoly LLC38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cartilage Injury Defect of Articular Cartilage Cartilage Damage

Interventions

BioPoly RS Partial Resurfacing Knee ImplantDEVICE

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (5)

Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester

Chester, England, United Kingdom

Aintree University Hospital

Liverpool, England, United Kingdom

The London Clinic

London, England, United Kingdom

Charing Cross Hospital

London, England, United Kingdom

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Knee function assessment

Time frame: 6 months

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Knee function assessment

Time frame: 2 years

Secondary Outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Knee function assessment

Time frame: Through 5 years

VAS Pain

Visual analogue scale for assessment of pain

Time frame: Through 5 years

Tegner Activity

Measurement of patient's activity level

Time frame: Through 5 years

SF-36

Assessment of patient's overall quality of life

Time frame: Through 5 years

Data from ClinicalTrials.gov

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