Trial record 2 of 2 for:    biopoly rs

BioPoly RS Knee Registry Study for Cartilage Defect Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01473199
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : April 18, 2016
Information provided by (Responsible Party):
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. Patients will be followed for 5 years after surgery.

Condition or disease Intervention/treatment Phase
Cartilage Injury Defect of Articular Cartilage Cartilage Damage Device: BioPoly RS Partial Resurfacing Knee Implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant
Study Start Date : November 2011

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 6 months ]
    Knee function assessment

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 2 years ]
    Knee function assessment

Secondary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Through 5 years ]
    Knee function assessment

  2. VAS Pain [ Time Frame: Through 5 years ]
    Visual analogue scale for assessment of pain

  3. Tegner Activity [ Time Frame: Through 5 years ]
    Measurement of patient's activity level

  4. SF-36 [ Time Frame: Through 5 years ]
    Assessment of patient's overall quality of life

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01473199

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
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

Responsible Party: BioPoly LLC Identifier: NCT01473199     History of Changes
Other Study ID Numbers: 1151001
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

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

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