Prospective Data Collection on Cementless Oxford Partial Knee

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00760188
• Collaborator: (none)
• Enrollment: 0
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Knee	Device: 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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Clinical Evaluation of the Cementless Oxford Partial Knee
• Actual Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Outcome Measures

Primary Outcome Measures

1. 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

1. Radiographic Assessment [1yr]

   x-ray evaluation

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rami Sorial , FRACS	Penrith		Australia

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Study Director: N Hunt, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00760188
• Other Study ID Numbers: BMET AU 01
• First Posted: Sep 26, 2008
• Last Update Posted: Sep 5, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Zimmer Biomet: knee replacement

Study Results

No Results Posted as of Sep 5, 2017