Prospective Data Collection on Cementless Oxford Partial Knee

Withdrawn

• Conditions: Arthroplasty, Replacement, Knee

• Registration Number: NCT00760188
• Lead Sponsor: Zimmer Biomet

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 Timeline

• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Study Start: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
American Knee Society Score	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 Outcome Measures

Name	Time	Method
Short Form 12	1 yr	Short Form 12: Multipurpose short form generic general health measure. The questionnaire looks at physical and mental scores for patients.
Oxford Knee Score	1 yr	Oxford Knee Score: Assess the impact that knee pain has on an individual's daily life. The survey consists of 12 self reported questions, where a higher score corresponds with a better outcome.
Radiographic Assessment	1yr	x-ray evaluation

Trial Locations

Locations (1)

Rami Sorial , FRACS; 🇦🇺 Penrith, Australia