Clinical trial NCT01473199: BioPoly RS Knee Registry Study for Cartilage Defect Replacement
Official title: Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage Injury
Defect of Articular Cartilage
Cartilage Damage
Keywords: focal defect
focal lesion
chondral lesion
osteochondral lesion
Lead sponsor: BioPoly LLC
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 months
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 2 years
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Through 5 years
measure: VAS Pain
timeFrame: Through 5 years
measure: Tegner Activity
timeFrame: Through 5 years
measure: SF-36
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Chester
country: United Kingdom
facility: Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester
state: England
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
state: England
city: London
country: United Kingdom
facility: The London Clinic
state: England
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: England
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
state: England
Study officials:
affiliation: Nuffield Health, The Grosvenor Hospital Chester
name: Vladimir Bobic, MD
role: STUDY_CHAIR
affiliation: The London Clinic
name: Dinesh Nathwani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aintree University Hospital
name: Michael McNicholas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal National Orthopaedic Hospital
name: Alister Hart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.