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BioPoly RS Knee Registry Study for Cartilage Defect Replacement

NCT01473199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-02-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • BioPoly LLC

    lead INDUSTRY

Principal Investigators

  • Vladimir Bobic, MD · Nuffield Health, The Grosvenor Hospital Chester

  • Dinesh Nathwani, MD · The London Clinic

  • Michael McNicholas, MD · Aintree University Hospital

  • Alister Hart, MD · Royal National Orthopaedic Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-12-31
Completion
2021-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01473199 on ClinicalTrials.gov