BioPoly RS Knee Registry Study for Cartilage Defect Replacement | Recruiting
BioPoly RS Knee Registry Study for Cartilage Defect Replacement
Health Conditions
  • Cartilage Injury
  • Defect of Articular Cartilage
  • Cartilage Damage
Recruiting
Recruitment Status
NCT01473199
Primary Trial ID Number
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. Patients will be followed for 5 years after surgery.
Primary Outcome Measures
  • Knee Injury and Osteoarthritis Outcome Score (KOOS); 6 months; Knee Injury and Osteoarthritis Outcome Score (KOOS); 2 years
Secondary Outcome Measures
  • Knee Injury and Osteoarthritis Outcome Score (KOOS); Through 5 years; VAS Pain; Through 5 years; Tegner Activity; Through 5 years; SF-36; Through 5 years
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
21 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
35
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Device; 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.; [BioPoly RS Implant]
Design Details
Sorry, this information is not available
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant
Secondary Trial Identifying Number
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Website
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Study Funded By
BioPoly LLC
Funder Type
Sorry, this information is not available
Study Sponsored By
BioPoly LLC
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

10 Nov 2011

Last Updated

23 Apr 2015

Date Record Refreshed on UKCTG

31 Jul 2015