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Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Total knee arthroplasty: mobile bearing
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • HOSR

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

TKA mobile

TKA

Arm Description

TKA mobile

TKA fix

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Number of Participants With Dislocation
count of numbers of dislocated implants.

Full Information

First Posted
January 3, 2007
Last Updated
April 7, 2020
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00417859
Brief Title
Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
Official Title
Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TKA mobile
Arm Type
Active Comparator
Arm Description
TKA mobile
Arm Title
TKA
Arm Type
No Intervention
Arm Description
TKA fix
Intervention Type
Device
Intervention Name(s)
Total knee arthroplasty: mobile bearing
Intervention Description
Total knee arthroplasty: mobile bearing
Primary Outcome Measure Information:
Title
Gait Stride Length
Description
distance in meters of gait stride lenght measured by a data logger with five inertial sensors
Time Frame
5years
Title
EuroQoL Quality of Life Scale (EQ-5D)
Description
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.
Time Frame
5years
Secondary Outcome Measure Information:
Title
Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures
Description
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.
Time Frame
5years
Title
Number of Participants With Dislocation
Description
count of numbers of dislocated implants.
Time Frame
5years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement Informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B Jolles, MD MSc
Organizational Affiliation
HOSR
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOSR
City
Lausanne
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

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