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Prospective Data Collection on Cementless Oxford Partial Knee

This study has been withdrawn prior to enrollment.
(No patients recruited into study.)
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT00760188
First received: September 25, 2008
Last updated: December 13, 2011
Last verified: November 2011
  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 ]

Secondary Outcome Measures:
  • Radiographic Assessment [ Time Frame: 1yr ]
  • Oxford Knee Score, SF12 [ Time Frame: 1 yr ]

Enrollment: 0
Study Start Date: July 2004
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients Received Cementless Oxford Partial Knee
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760188

Locations
Australia
Rami Sorial , FRACS
Penrith, Australia
Sponsors and Collaborators
Zimmer Biomet
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00760188     History of Changes
Other Study ID Numbers: BMET AU 01
Study First Received: September 25, 2008
Last Updated: December 13, 2011

Keywords provided by Zimmer Biomet:
knee replacement

ClinicalTrials.gov processed this record on April 24, 2017