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Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis

This study is not yet open for participant recruitment.
Verified December 2011 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by (Responsible Party):
Dr. G. Dervin, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00967161
First received: August 26, 2009
Last updated: December 20, 2011
Last verified: December 2011
History of Changes

August 26, 2009
December 20, 2011
January 2012
June 2015   (final data collection date for primary outcome measure)
The motion analysis assessments of the knee [ Time Frame: pre-op,6,12 months following surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00967161 on ClinicalTrials.gov Archive Site
Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey. [ Time Frame: pre-op,6,12 and 24 months ] [ Designated as safety issue: No ]
Questionnaires: (SF-12),(TKFQ),(KOOS)and satisfaction [ Time Frame: pre-op,6,12 and 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis
3D Motion Analysis of Evolution Medial Pivot Knee VS Posterior Stabilized Knee Arthroplasty for Osteoarthritis of the Knee.Feasibility Pilot for a Prospective Randomized Controlled Trial.

The purpose of the current study is to analyze and compare the lower-limb joint motions and muscle activation patterns during activities of daily living as well as self reported health related functional outcomes for patients with osteoarthritis of the knee undergoing one of two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).

Inclusion:

40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.

Patients who do not meet any exclusion criteria.

Exclusion:

Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.

Exclusion for patient group

  1. Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
  2. Patients with any other joint replacement in the ipsilateral and contralateral limb.
  3. Patients with evidence of active infection.
  4. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
  5. Patients with neuropathic joints.
  6. Patients requiring structural bone grafts.
  7. Patients with a documented allergy to cobalt chromium molybdenum.
  8. Patient with a BMI larger than 30 kg/m2.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Arthropathy of Knee Joint
  • Procedure: Total Knee Arthroplasty
    Total Knee Arthroplasty
    Other Name: non applicable
  • Procedure: Motion analysis
    Motion analysis (Gait/EMG during walking and functional tasks)
    Other Name: non applicable
  • Experimental: Evolution Medial Pivot Knee
    20 Patients will receive the EMP Knee Implant
    Interventions:
    • Procedure: Total Knee Arthroplasty
    • Procedure: Motion analysis
  • Active Comparator: Triathlon PS Knee
    20 Patients will receive the Triathlon PS Knee
    Interventions:
    • Procedure: Total Knee Arthroplasty
    • Procedure: Motion analysis
  • No Intervention: Control Group
    10 Age, Gender, BMI-matched control participants
    Intervention: Procedure: Motion analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.Patients who do not meet any exclusion criteria.

Exclusion Criteria:

  • Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.

Exclusion for patient group

  1. Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
  2. Patients with any other joint replacement in the ipsilateral and contralateral limb.
  3. Patients with evidence of active infection.
  4. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
  5. Patients with neuropathic joints.
  6. Patients requiring structural bone grafts.
  7. Patients with a documented allergy to cobalt chromium molybdenum.
  8. Patient with a BMI larger than 30 kg/m2.
Both
50 Years to 75 Years
Yes
Contact: Geoffrey Dervin, MD,MSc,FRCSC 613-737-8081 gdervin@ottawahospital.on.ca
Contact: Mario Lamontagne, Professor 613-562-5800 ext 4258 mlamon@uottawa.ca
Canada
 
NCT00967161
OHREB 2009-240-01H
No
Dr. G. Dervin, Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Wright Medical Technology
Principal Investigator: Geoffrey Dervin, MD,MSc,FRCSC OHRI / The Ottawa Hospital/ University of Ottawa
Ottawa Hospital Research Institute
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP