Total Knee Replacement With Duracon® and Vanguard™ Prostheses

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: June 9, 2009

Verified by: Biomet, Inc., June 2009

Clinical Trial Phase: N/A | Start Date: June 2005

Overall Status: Terminated

Estimated Enrollment: 150

Brief Summary

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

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 July 02, 2009

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

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