We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Data Collection on Cementless Oxford Partial Knee

This study has been withdrawn prior to enrollment.
(No patients recruited into study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760188
First Posted: September 26, 2008
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee.

Condition Intervention
Arthroplasty, Replacement, Knee Device: Cementless Oxford Partial Knee

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical Evaluation of the Cementless Oxford Partial Knee

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Radiographic Assessment [ Time Frame: 1yr ]
    x-ray evaluation

  • Oxford Knee Score [ Time Frame: 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.

  • Short Form 12 [ Time Frame: 1 yr ]
    Short Form 12: Multipurpose short form generic general health measure. The questionnaire looks at physical and mental scores for patients.


Enrollment: 0
Actual Study Start Date: December 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Cementless Oxford Partial Knee
    Cementless Oxford Partial Knee Replacement
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760188


Locations
Australia
Rami Sorial , FRACS
Penrith, Australia
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: N Hunt Zimmer Biomet
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00760188     History of Changes
Other Study ID Numbers: BMET AU 01
First Submitted: September 25, 2008
First Posted: September 26, 2008
Last Update Posted: September 4, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share Individual Patient Data.

Keywords provided by Zimmer Biomet:
knee replacement