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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioPoly RS Implant | Experimental | BioPoly RS Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioPoly RS Partial Resurfacing Knee Implant | Device | A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | 6 months |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee function assessment | Through 5 years |
| VAS Pain | Visual analogue scale for assessment of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Bobic, MD | Nuffield Health, The Grosvenor Hospital Chester | Study Chair |
| Dinesh Nathwani, MD | The London Clinic | Principal Investigator |
| Michael McNicholas, MD | Aintree University Hospital | Principal Investigator |
| Alister Hart, MD | Royal National Orthopaedic Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester | Chester | England | CH4 7QP | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30229214 | Result | 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. |
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| Through 5 years |
| Tegner Activity | Measurement of patient's activity level | Through 5 years |
| SF-36 | Assessment of patient's overall quality of life | Through 5 years |
| Aintree University Hospital |
| Liverpool |
| England |
| L9 7AL |
| United Kingdom |
| The London Clinic | London | England | W1G 6HL | United Kingdom |
| Charing Cross Hospital | London | England | W6 8RF | United Kingdom |
| Royal National Orthopaedic Hospital | Stanmore | England | HA7 4LP | United Kingdom |