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NCT Number: NCT01473199

BioPoly RS Knee Registry Study for Cartilage Defect Replacement

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.

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Key information

Conditions

Cartilage Injury Cartilage Damage Defect of Articular Cartilage

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester, Chester, England, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 6 months

    Knee function assessment

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 2 years

    Knee function assessment

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Through 5 years

    Knee function assessment

  2. VAS Pain

    Time frame: Through 5 years

    Visual analogue scale for assessment of pain

  3. Tegner Activity

    Time frame: Through 5 years

    Measurement of patient's activity level

  4. SF-36

    Time frame: Through 5 years

    Assessment of patient's overall quality of life

Sponsors and collaborators

Lead sponsor

BioPoly LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2021
First posted
Nov 17, 2011
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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