BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Not Applicable

Completed

• Conditions: Cartilage Damage; Cartilage Injury; Defect of Articular Cartilage
• Interventions: Device: BioPoly RS Partial Resurfacing Knee Implant

• Registration Number: NCT01473199
• Lead Sponsor: BioPoly LLC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Primary Completion: 2016-12
• Study Completion: 2021-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BioPoly RS Implant	BioPoly RS Partial Resurfacing Knee Implant	BioPoly RS Implant

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)	2 years	Knee function assessment

Secondary Outcome Measures

Name	Time	Method
Tegner Activity	Through 5 years	Measurement of patient's activity level
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Through 5 years	Knee function assessment
VAS Pain	Through 5 years	Visual analogue scale for assessment of pain
SF-36	Through 5 years	Assessment of patient's overall quality of life

Trial Locations

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

Royal National Orthopaedic Hospital; 🇬🇧 Stanmore, England, United Kingdom

Charing Cross Hospital; 🇬🇧 London, England, United Kingdom