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This study has been withdrawn prior to enrollment.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

Tracking Information
First Received Date ^ICMJE	September 25, 2008
Last Updated Date	December 13, 2011
Start Date ^ICMJE	July 2004
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 25, 2008)	American Knee Society Score [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00760188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 25, 2008)	Radiographic Assessment [ Time Frame: 1yr ] [ Designated as safety issue: Yes ] Oxford Knee Score, SF12 [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prospective Data Collection on Cementless Oxford Partial Knee
Official Title ^ICMJE	Prospective Clinical Evaluation of the Cementless Oxford Partial Knee
Brief Summary	Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee.
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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
Condition ^ICMJE	Arthroplasty, Replacement, Knee
Intervention ^ICMJE	Device: Cementless Oxford Partial Knee Cementless Oxford Partial Knee Replacement
Study Group/Cohort (s)	1 Patients Received Cementless Oxford Partial Knee Intervention: Device: Cementless Oxford Partial Knee
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia

Administrative Information
NCT Number ^ICMJE	NCT00760188
Other Study ID Numbers ^ICMJE	BMET AU 01
Has Data Monitoring Committee	No
Responsible Party	Biomet, Inc.
Study Sponsor ^ICMJE	Biomet, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biomet, Inc.
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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