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BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Primary Purpose

Cartilage Injury, Defect of Articular Cartilage, Cartilage Damage

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
BioPoly RS Partial Resurfacing Knee Implant
Sponsored by
BioPoly LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cartilage Injury focused on measuring focal defect, focal lesion, chondral lesion, osteochondral lesion

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester
  • Aintree University Hospital
  • The London Clinic
  • Charing Cross Hospital
  • Royal National Orthopaedic Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BioPoly RS Implant

Arm Description

BioPoly RS Implant

Outcomes

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment

Secondary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment
VAS Pain
Visual analogue scale for assessment of pain
Tegner Activity
Measurement of patient's activity level
SF-36
Assessment of patient's overall quality of life

Full Information

First Posted
November 10, 2011
Last Updated
January 17, 2022
Sponsor
BioPoly LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01473199
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioPoly LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Injury, Defect of Articular Cartilage, Cartilage Damage
Keywords
focal defect, focal lesion, chondral lesion, osteochondral lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BioPoly RS Implant
Arm Type
Experimental
Arm Description
BioPoly RS Implant
Intervention Type
Device
Intervention Name(s)
BioPoly RS Partial Resurfacing Knee Implant
Intervention Description
A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Knee function assessment
Time Frame
6 months
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Knee function assessment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Knee function assessment
Time Frame
Through 5 years
Title
VAS Pain
Description
Visual analogue scale for assessment of pain
Time Frame
Through 5 years
Title
Tegner Activity
Description
Measurement of patient's activity level
Time Frame
Through 5 years
Title
SF-36
Description
Assessment of patient's overall quality of life
Time Frame
Through 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Bobic, MD
Organizational Affiliation
Nuffield Health, The Grosvenor Hospital Chester
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dinesh Nathwani, MD
Organizational Affiliation
The London Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael McNicholas, MD
Organizational Affiliation
Aintree University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alister Hart, MD
Organizational Affiliation
Royal National Orthopaedic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester
City
Chester
State/Province
England
ZIP/Postal Code
CH4 7QP
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
The London Clinic
City
London
State/Province
England
ZIP/Postal Code
W1G 6HL
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Royal National Orthopaedic Hospital
City
Stanmore
State/Province
England
ZIP/Postal Code
HA7 4LP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30229214
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.
Results Reference
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BioPoly RS Knee Registry Study for Cartilage Defect Replacement

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