Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brigitte Jolles, MD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00417859
First received: January 3, 2007
Last updated: November 10, 2014
Last verified: November 2014
  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
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TKA
TKA
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, MD, 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: November 10, 2014
Health Authority: Switzerland: Institutional Review Board

ClinicalTrials.gov processed this record on March 30, 2015