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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This study has been withdrawn prior to enrollment.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: August 31, 2017
Last verified: July 2017
September 25, 2008
August 31, 2017
December 2011
December 2011   (Final data collection date for primary outcome measure)
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.
American Knee Society Score [ Time Frame: 1 yr ]
Complete list of historical versions of study NCT00760188 on ClinicalTrials.gov Archive Site
  • 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.
  • Radiographic Assessment [ Time Frame: 1yr ]
  • Oxford Knee Score, SF12 [ Time Frame: 1 yr ]
Not Provided
Not Provided
 
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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
Arthroplasty, Replacement, Knee
Device: Cementless Oxford Partial Knee
Cementless Oxford Partial Knee Replacement
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2011
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00760188
BMET AU 01
No
Not Provided
Plan to Share IPD: No
Plan Description: There is no plan to share Individual Patient Data.
Zimmer Biomet
Zimmer Biomet
Not Provided
Study Director: N Hunt Zimmer Biomet
Zimmer Biomet
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP