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BioPoly RS Knee Registry Study for Cartilage Defect Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioPoly LLC
ClinicalTrials.gov Identifier:
NCT01473199
First received: November 10, 2011
Last updated: April 15, 2016
Last verified: April 2016
  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:


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


Enrollment: 38
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473199

Locations
United Kingdom
Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester
Chester, England, United Kingdom, CH4 7QP
Aintree University Hospital
Liverpool, England, United Kingdom, L9 7AL
The London Clinic
London, England, United Kingdom, W1G 6HL
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Royal National Orthopaedic Hospital
Stanmore, England, United Kingdom, HA7 4LP
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: Michael McNicholas, MD Aintree University Hospital
Principal Investigator: Alister Hart, MD Royal National Orthopaedic Hospital
  More Information

Responsible Party: BioPoly LLC
ClinicalTrials.gov Identifier: NCT01473199     History of Changes
Other Study ID Numbers: 1151001 
Study First Received: November 10, 2011
Last Updated: April 15, 2016
Health Authority: United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 26, 2016