Prospective Data Collection on Cementless Oxford Partial Knee

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Prospective Clinical Evaluation of the Cementless Oxford Partial Knee

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00760188
• Other study ID #: BMET AU 01
• Status: Withdrawn
• Phase: N/A
• First received: September 25, 2008
• Last updated: August 31, 2017
• Start date: December 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Cementless Oxford Partial Knee
Cementless Oxford Partial Knee Replacement

Locations

Country	Name	City	State
Australia	Rami Sorial , FRACS	Penrith

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Knee Society Score	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.	1 yr
Secondary	Radiographic Assessment	x-ray evaluation	1yr
Secondary	Oxford Knee Score	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.	1 yr
Secondary	Short Form 12	Short Form 12: Multipurpose short form generic general health measure. The questionnaire looks at physical and mental scores for patients.	1 yr