ClinicalTrials.gov
ClinicalTrials.gov Menu

Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00417859
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Brigitte Jolles, MD, University of Lausanne Hospitals

Brief Summary:
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 or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Total knee arthroplasty: mobile bearing Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
Study Start Date : February 2004
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: TKA mobile
TKA mobile
Device: Total knee arthroplasty: mobile bearing
Total knee arthroplasty: mobile bearing
No Intervention: TKA
TKA fix



Primary Outcome Measures :
  1. Gait [ Time Frame: Pre-op;1year;5years;10years ]
  2. Subjective evaluation EQ-5D; WOMAC, VAS pain [ Time Frame: Pre-op;1year;5years;10years ]
  3. Semi-objective evaluation KSS clinical and radiological [ Time Frame: Pre-op;1year;5years;10years ]

Secondary Outcome Measures :
  1. Dislocation [ Time Frame: Pre-op;1year;5years;10years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417859


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

Responsible Party: Brigitte Jolles, MD, Prof, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00417859     History of Changes
Other Study ID Numbers: HO 218/01
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

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