This trial is active, not recruiting.

Condition knee osteoarthritis
Treatment total knee arthroplasty: mobile bearing
Phase phase 4
Sponsor University of Lausanne Hospitals
Start date February 2004
End date November 2015
Trial size 64 participants
Trial identifier NCT00417859, HO 218/01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
total knee arthroplasty: mobile bearing
Total knee arthroplasty: mobile bearing

Primary Outcomes

time frame: Pre-op;1year;5years;10years
Subjective evaluation EQ-5D; WOMAC, VAS pain
time frame: Pre-op;1year;5years;10years
Semi-objective evaluation KSS clinical and radiological
time frame: Pre-op;1year;5years;10years

Secondary Outcomes

time frame: Pre-op;1year;5years;10years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement - Informed consent

Additional Information

Official title Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
Principal investigator B Jolles, MD MSc
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University of Lausanne Hospitals.