BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant

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.

Study Overview

• Status: Completed
• Conditions: Cartilage Injury; Defect of Articular Cartilage; Cartilage Damage
• Intervention / Treatment: Device: BioPoly RS Partial Resurfacing Knee Implant

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Chester, England, United Kingdom, CH4 7QP
      • Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester
    • Liverpool, England, United Kingdom, L9 7AL
      • Aintree University Hospital
    • London, England, United Kingdom, W6 8RF
      • Charing Cross Hospital
    • London, England, United Kingdom, W1G 6HL
      • The London Clinic
    • Stanmore, England, United Kingdom, HA7 4LP
      • Royal National Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: BioPoly LLC
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: chondral lesion; osteochondral lesion; focal defect; focal lesion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: 1151001