Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

Not Applicable

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT00417859
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-03
• Study First Posted: 2007-01-04
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2020-02-27
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-06
• Results First Posted: 2020-04-07
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait Stride Length	5years	distance in meters of gait stride lenght measured by a data logger with five inertial sensors
EuroQoL Quality of Life Scale (EQ-5D)	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.

Secondary Outcome Measures

Name	Time	Method
Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures	5years	Scoring system to clinically rate the knee abefore and after TK, scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Number of Participants With Dislocation	5years	count of numbers of dislocated implants.

Trial Locations

Locations (1)

HOSR; 🇨🇭 Lausanne, Switzerland