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.

Study Overview

• Status: Withdrawn
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: 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 Type: Observational

Contacts and Locations

Study Locations

• Australia
  • Penrith, Australia
    • Rami Sorial , FRACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Assessment	x-ray evaluation	1yr
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
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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: N Hunt, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (ESTIMATE): September 26, 2008

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: knee replacement
• Other Study ID Numbers: BMET AU 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share Individual Patient Data.