BioPoly RS Knee Registry Study for Cartilage Defect Replacement

NCT01473199 | Completed

• 1 other identifier: 1151001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 5

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.

Conditions

Cartilage Injury; Defect of Articular Cartilage; Cartilage Damage

Keywords

focal defect; focal lesion; chondral lesion; osteochondral lesion

Outcome Measures

Primary Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Knee function assessment

  6 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Knee function assessment

  2 years

Secondary Outcomes (4)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Through 5 years

• VAS Pain

  Through 5 years

• Tegner Activity

  Through 5 years

• SF-36

  Through 5 years

Study Arms (1)

BioPoly RS Implant

EXPERIMENTAL

BioPoly RS Implant

Device: BioPoly RS Partial Resurfacing Knee Implant

Interventions

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.

BioPoly RS Implant

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioPoly LLC: lead

Study Sites (5)

Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester

Chester, England, CH4 7QP, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

The London Clinic

London, England, W1G 6HL, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Royal National Orthopaedic Hospital

Stanmore, England, HA7 4LP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30229214 RESULT

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 17, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

GB (5)