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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
  Purpose

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).


Condition Intervention
Arthropathy of Knee Joint
 Procedure: Total Knee Arthroplasty
Procedure: Motion analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • The motion analysis assessments of the knee [ Time Frame: pre-op,6,12 months following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evolution Medial Pivot Knee
20 Patients will receive the EMP Knee Implant
 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
Active Comparator: Triathlon PS Knee
20 Patients will receive the Triathlon PS Knee
 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
No Intervention: Control Group
10 Age, Gender, BMI-matched control participants
 Procedure: Motion analysis
Motion analysis (Gait/EMG during walking and functional tasks)
Other Name: non applicable

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967161

Contacts
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

Locations
Canada, Ontario
The Ottawa General Hospital Active, not recruiting
Ottawa, Ontario, Canada, k1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Wright Medical Technology
Investigators
Principal Investigator: Geoffrey Dervin, MD,MSc,FRCSC OHRI / The Ottawa Hospital/ University of Ottawa
  More Information

No publications provided

Responsible Party: Dr. G. Dervin, Chair, Orthopaedic Surgery, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00967161     History of Changes
Other Study ID Numbers: OHREB 2009-240-01H
Study First Received: August 26, 2009
Last Updated: December 20, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
knee replacement motion analysis

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Osteoarthritis, Knee
 Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013