Cartilage Injury Clinical Trial
Official title:
Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant
NCT number | NCT01473199 |
Other study ID # | 1151001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2011 |
Est. completion date | December 2021 |
Verified date | January 2022 |
Source | BioPoly LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 2021 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester | Chester | England |
United Kingdom | Aintree University Hospital | Liverpool | England |
United Kingdom | Charing Cross Hospital | London | England |
United Kingdom | The London Clinic | London | England |
United Kingdom | Royal National Orthopaedic Hospital | Stanmore | England |
Lead Sponsor | Collaborator |
---|---|
BioPoly LLC |
United Kingdom,
Nathwani D, McNicholas M, Hart A, Miles J, Bobic V. Partial Resurfacing of the Knee with the BioPoly Implant: Interim Report at 2 Years. JB JS Open Access. 2017 Apr 6;2(2):e0011. doi: 10.2106/JBJS.OA.16.00011. eCollection 2017 Jun 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | 6 months | |
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | 2 years | |
Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | Through 5 years | |
Secondary | VAS Pain | Visual analogue scale for assessment of pain | Through 5 years | |
Secondary | Tegner Activity | Measurement of patient's activity level | Through 5 years | |
Secondary | SF-36 | Assessment of patient's overall quality of life | Through 5 years |
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