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Clinical Trials/NCT00760188
NCT00760188
Withdrawn
Not Applicable

Prospective Clinical Evaluation of the Cementless Oxford Partial Knee

Zimmer Biomet1 site in 1 countryDecember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty, Replacement, Knee
Sponsor
Zimmer Biomet
Locations
1
Primary Endpoint
American Knee Society Score
Status
Withdrawn
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
December 2011
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

American Knee Society Score

Time Frame: 1 yr

The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.

Secondary Outcomes

  • Short Form 12(1 yr)
  • Oxford Knee Score(1 yr)
  • Radiographic Assessment(1yr)

Study Sites (1)

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