Prospective Data Collection on Cementless Oxford Partial Knee - Full Text View

Sponsored by:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00760188

Purpose

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

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

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
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:

Patients undergoing primary knee arthroplasty
Patients with one of the following primary diagnoses in the medial compartment of the knee:
- Osteoarthritis,
- Avascular necrosis

Exclusion criteria:

Inability to co-operate with and complete the study.
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	Recruiting
Penrith, Australia
Contact: R Sorial, FRACS 02.4721.2217

Sponsors and Collaborators

Biomet, Inc.

More Information

Responsible Party:	Biomet Australia ( Andy Round )
Study ID Numbers:	BMET AU 01
Study First Received:	September 25, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00760188
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 January 14, 2009