The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses...
Date First Received: December 21, 2007
Last Updated: July 3, 2008
Verified by: Biomet, Inc., July 2008
Clinical Trial Phase: N/A | Start Date: June 2005
Overall Status: Active, not recruiting
Estimated Enrollment: 150
Brief Summary
Condition Keyword(s):
Intervention(s):
The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.
Study Type: Observational
Study Design: Cohort, Prospective
Study Primary Completion Date: February 2008
Intervention(s) in this Clinical Trial
- Device: Duracon®
- This group utilizes the Duracon® prostheses for total knee replacement.
- Device: Vanguard™
- This group will utilize the Vanguard™ prostheses for total knee replacement.
Arms, Groups and Cohorts in this Clinical Trial
- : 1
- : 2
Outcome Measures for this Clinical Trial
Primary Measures
- Range of motion, Knee Society Score, Duration of surgery
- Time Frame: 1 year
Safety Issue?: No
- Time Frame: 1 year
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Patients requiring correction of varus, valgus, or posttraumatic deformity.
- Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Exclusion Criteria:
- Patients with infection, sepsis, or osteomyelitis.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Biomet Orthopedics, LLC
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00588887
Study ID Number: 105-U-014
ClinicalTrials.gov Identifier: NCT00588887
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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