Cemented or Cementless Oxford Partial Knee - a Randomized Controlled Trial (RCT)
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Cemented Oxford Partial Knee Replacement (Device); Cementless Oxford Partial Knee Replacement (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
David Murray, Professor, Principal Investigator, Affiliation: Nuffield Orthopaedic Centre General Charity 93-08 /
Overall contact:
David Stephenson, PhD, Email: david.stephenson@biometeurope.com
Summary
This study intends to compare cementless and cemented Oxford Knees using in clinical and
radiographic outcome measures.
Clinical Details
Official title: Cemented or Cementless Oxford Partial Knee - a Randomized Controlled Trial
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Radiographic Assessment
Secondary outcome: Oxford Knee ScoreAmerican Knee Score Complication RSA Assessment
Detailed description:
The aim of this study is to compare a cementless partial knee replacement with a cemented
partial knee replacement. Patients are randomised to receive either a cementless or a
cemented Oxford Knee. All patients will be followed up with clinical and radiological
assessment including American Knee Society Scores and Oxford Knee Scores. Implant migration
will be measured using radiostereometric analysis (RSA) and the occurrence and progression of
radiolucency will be assessed from fluoroscopically aligned radiographs.
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion :
- Healthy subjects with one of the following primary diagnoses in the medial compartment
of the knee:
Osteoarthritis, Avascular necrosis, suitable for Oxford Partial Knee Replacement
Exclusion:
- Subjects with severe limiting systemic illness
- Subjects who are too large for RSA analysis due to limitations of the RSA set up
Locations and Contacts
David Stephenson, PhD, Email: david.stephenson@biometeurope.com
Nuffield Orthopaedic Hospital, Headington, Oxford OX3 7LD, United Kingdom; Recruiting
David Murray, Professor, Phone: : +44 1865 227457
Additional Information
Starting date: November 2002
Ending date: November 2011
Last updated: September 26, 2008
|
