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BioPoly RS Knee Registry Study for Cartilage Defect Replacement

This study is currently recruiting participants.
Verified February 2013 by BioPoly LLC
Sponsor:
Information provided by (Responsible Party):
BioPoly LLC
ClinicalTrials.gov Identifier:
NCT01473199
First received: November 10, 2011
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Cartilage Injury
Defect of Articular Cartilage
Cartilage Damage
 Device: BioPoly RS Partial Resurfacing Knee Implant

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioPoly LLC:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Knee function assessment

  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Knee function assessment


Secondary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
    Knee function assessment

  • VAS Pain [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
    Visual analogue scale for assessment of pain

  • Tegner Activity [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
    Measurement of patient's activity level

  • SF-36 [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
    Assessment of patient's overall quality of life


Estimated Enrollment: 35
Study Start Date: November 2011
Arms Assigned Interventions
Experimental: BioPoly RS Implant 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473199

Locations
United Kingdom
Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester Recruiting
Chester, England, United Kingdom, CH4 7QP
Contact: Vladimir Bobic, MD     01244 881 931     office@kneeclinic.info    
Principal Investigator: Vladimir Bobic, MD            
Aintree University Hospital Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Michael McNicholas, MD     0151 529 2548     mmcnicholas@mcnicholaskneeclinic.co.uk    
Principal Investigator: Michael McNicholas, MD            
The London Clinic Recruiting
London, England, United Kingdom, W1G 6HL
Contact: Dinesh Nathwani     02070346125     info@precisionsurgery.co.uk    
Principal Investigator: Dinesh Nathwani, MD            
London Bridge Hospital Recruiting
London, England, United Kingdom, SE1 2PR
Contact: Ian McDermott, MD     08445 617157     london@sportsortho.co.uk    
Principal Investigator: Ian McDermott, MD            
Sponsors and Collaborators
BioPoly LLC
Investigators
Study Chair: Vladimir Bobic, MD Nuffield Health, The Grosvenor Hospital Chester
Principal Investigator: Dinesh Nathwani, MD The London Clinic
Principal Investigator: Ian McDermott, MD London Bridge Hospital
Principal Investigator: Michael McNicholas, MD Aintree University Hospital
  More Information

No publications provided

Responsible Party: BioPoly LLC
ClinicalTrials.gov Identifier: NCT01473199     History of Changes
Other Study ID Numbers: 1151001
Study First Received: November 10, 2011
Last Updated: February 11, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by BioPoly LLC:
focal defect
focal lesion
chondral lesion
osteochondral lesion

ClinicalTrials.gov processed this record on May 16, 2013