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Prospective Data Collection on Cementless Oxford Partial Knee

This study has been withdrawn prior to enrollment.
(No patients recruited into study.)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00760188
First received: September 25, 2008
Last updated: December 13, 2011
Last verified: November 2011
History of Changes
  Purpose

Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee.


Condition Intervention
Arthroplasty, Replacement, Knee
 Device: Cementless Oxford Partial Knee

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical Evaluation of the Cementless Oxford Partial Knee

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • American Knee Society Score [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic Assessment [ Time Frame: 1yr ] [ Designated as safety issue: Yes ]
  • Oxford Knee Score, SF12 [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2004
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients Received Cementless Oxford Partial Knee
 Device: Cementless Oxford Partial Knee
Cementless Oxford Partial Knee Replacement

Detailed Description:

Prospective radiographic and clinical data collection on outcomes of Cementless oxford Partial Knee. Screened radiographs are taken postoperatively and after 12 months. Oxford Knee Scores, SF12 Health Questionnaires and American Knee Society Radiographic Assessment are taken at 12 month follow-up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients Who Received Cementless Oxford Partial Knee for Its Indications for Use/Intended Uses - primary diagnoses in the medial compartment of the knee:

  • Osteoarthritis,
  • Avascular necrosis
Criteria

Inclusion Criteria:

  1. Patients undergoing primary knee arthroplasty

  2. Patients with one of the following primary diagnoses in the medial compartment of the knee:

    • Osteoarthritis,
    • Avascular necrosis

Exclusion criteria:

  1. Inability to co-operate with and complete the study.
  2. Inadequate fixation of cementless components. If either before or after randomization the surgeon feels that cementless fixation is inadequate, cemented components should be inserted.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760188

Locations
Australia
Rami Sorial , FRACS
Penrith, Australia
Sponsors and Collaborators
Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00760188     History of Changes
Other Study ID Numbers: BMET AU 01
Study First Received: September 25, 2008
Last Updated: December 13, 2011
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by Biomet, Inc.:
knee replacement

ClinicalTrials.gov processed this record on May 19, 2013