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This study has been withdrawn prior to enrollment.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

September 25, 2008
December 13, 2011
July 2004
September 2012   (final data collection date for primary outcome measure)
American Knee Society Score [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00760188 on ClinicalTrials.gov Archive Site
  • Radiographic Assessment [ Time Frame: 1yr ] [ Designated as safety issue: Yes ]
  • Oxford Knee Score, SF12 [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prospective Data Collection on Cementless Oxford Partial Knee
Prospective Clinical Evaluation of the Cementless Oxford Partial Knee

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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
Arthroplasty, Replacement, Knee
Device: Cementless Oxford Partial Knee
Cementless Oxford Partial Knee Replacement
1
Patients Received Cementless Oxford Partial Knee
Intervention: Device: Cementless Oxford Partial Knee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00760188
BMET AU 01
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Not Provided
Biomet, Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP