Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

Knee Osteoarthritis Clinical Trial

Official title:

Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417859
• Other study ID #: HO 218/01
• Status: Completed
• Phase: N/A
• Start date: February 2004
• Est. completion date: November 2015

Study information

• Verified date: April 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Informed consent

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Total knee arthroplasty: mobile bearing
Total knee arthroplasty: mobile bearing

Locations

Country	Name	City	State
Switzerland	HOSR	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Stride Length	distance in meters of gait stride lenght measured by a data logger with five inertial sensors	5years
Primary	EuroQoL Quality of Life Scale (EQ-5D)	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.	5years
Secondary	Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures	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.	5years
Secondary	Number of Participants With Dislocation	count of numbers of dislocated implants.	5years