Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

University of Lausanne Hospitals1 site in 1 country64 target enrollmentFebruary 2004

ConditionsKnee Osteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: University of Lausanne Hospitals
Enrollment: 64
Locations: 1
Primary Endpoint: Gait Stride Length
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

November 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Lausanne Hospitals

Responsible Party

Principal Investigator

Brigitte Jolles, MD

Prof

University of Lausanne Hospitals

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Gait Stride Length

Time Frame: 5years

distance in meters of gait stride lenght measured by a data logger with five inertial sensors

EuroQoL Quality of Life Scale (EQ-5D)

Time Frame: 5years

The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time.