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Completed

NCT Number: NCT00417859

Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HOSR

Lausanne, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Total knee arthroplasty: mobile bearing

Device

Total knee arthroplasty: mobile bearing

Primary outcomes

  1. Gait Stride Length

    Time frame: 5years

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

  2. 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.

Secondary outcomes

  1. Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures

    Time frame: 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.

  2. Number of Participants With Dislocation

    Time frame: 5years

    count of numbers of dislocated implants.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Jan 4, 2007
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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