Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Lausanne Hospitals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Brigitte Jolles, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00417859
First received: January 3, 2007
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

The goal of this study is to provide gait parameters as a new objective method to assess total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an ambulatory device with minimal sensor configuration.


Condition Intervention Phase
Knee Osteoarthritis
Device: Total knee arthroplasty: mobile bearing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Gait [ Time Frame: Pre-op;1year;5years;10years ] [ Designated as safety issue: No ]
  • Subjective evaluation EQ-5D; WOMAC, VAS pain [ Time Frame: Pre-op;1year;5years;10years ] [ Designated as safety issue: No ]
  • Semi-objective evaluation KSS clinical and radiological [ Time Frame: Pre-op;1year;5years;10years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dislocation [ Time Frame: Pre-op;1year;5years;10years ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: February 2004
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Total knee arthroplasty: mobile bearing
    Total knee arthroplasty: mobile bearing
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement
  • Informed consent
  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: NCT00417859

Locations
Switzerland
HOSR
Lausanne, Switzerland
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: B Jolles, MD MSc HOSR
  More Information

No publications provided

Responsible Party: Brigitte Jolles, Prof, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00417859     History of Changes
Other Study ID Numbers: HO 218/01
Study First Received: January 3, 2007
Last Updated: March 22, 2012
Health Authority: Switzerland: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014