BioPoly RS Knee Registry Study for Cartilage Defect Replacement | Recruiting
BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Cartilage Injury
  • Defect of Articular Cartilage
  • Cartilage Damage
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT01473199
Primary Trial ID Number
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. Patients will be followed for 5 years after surgery.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Device : BioPoly RS Partial Resurfacing Knee Implant

Study Arm Groups : BioPoly RS Implant

Intervention Type
See Interventions above
Primary Outcome Measures
  • Knee Injury and Osteoarthritis Outcome Score (KOOS); 6 months; Knee Injury and Osteoarthritis Outcome Score (KOOS); 2 years
Secondary Outcome Measures
  • 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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
21 Years - N/A
Who Can Participate
Patients
Number of Participants
35
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Pfizer Investigational Site
London
W6 8RF
Aintree University Hospitals NHS Foundation Trust
Liverpool
Merseyside
L9 7AL
Pfizer Investigational Site
Stanmore
Middlesex
HA7 4LP
Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester
Chester
England
CH4 7QP
The London Clinic
London
England
W1G 6HL
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
1151001
Sponsor(s)
BioPoly LLC
Key Dates

Recruitment Start Date

Nov 2011

Recruitment End Date
Date Not Available
Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

10 Nov 2011

Last Updated

23 Apr 2015