Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Feb 2004
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 3, 2007
CompletedFirst Posted
Study publicly available on registry
January 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
April 7, 2020
CompletedApril 21, 2020
April 1, 2020
11.8 years
January 3, 2007
February 27, 2020
April 7, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Gait Stride Length
distance in meters of gait stride lenght measured by a data logger with five inertial sensors
5years
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 Outcomes (2)
Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures
5years
Number of Participants With Dislocation
5years
Study Arms (2)
TKA mobile
ACTIVE COMPARATORTKA mobile
TKA
NO INTERVENTIONTKA fix
Interventions
Eligibility Criteria
You may qualify if:
- Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement
- Informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HOSR
Lausanne, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof Brigitte Jolles
- Organization
- University Hospital of Lausanne
Study Officials
- PRINCIPAL INVESTIGATOR
B Jolles, MD MSc
HOSR
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
January 3, 2007
First Posted
January 4, 2007
Study Start
February 1, 2004
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
April 21, 2020
Results First Posted
April 7, 2020
Record last verified: 2020-04