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

November 17, 2015 updated by: Ottawa Hospital Research Institute

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, k1Y 4E9
        • The Ottawa General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evolution Medial Pivot Knee
20 Patients will receive the EMP Knee Implant
Procedure: Total Knee Arthroplasty
Total Knee Arthroplasty
Other Names:
  • non applicable
Procedure: Motion analysis
Motion analysis (Gait/EMG during walking and functional tasks)
Other Names:
  • non applicable
Active Comparator: Triathlon PS Knee
20 Patients will receive the Triathlon PS Knee
Procedure: Total Knee Arthroplasty
Total Knee Arthroplasty
Other Names:
  • non applicable
Procedure: Motion analysis
Motion analysis (Gait/EMG during walking and functional tasks)
Other Names:
  • non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The motion analysis assessments of the knee
Time Frame: pre-op,6,12 months following surgery
pre-op,6,12 months following surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.
Time Frame: pre-op,6,12 and 24 months
pre-op,6,12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Stryker Trauma GmbH

Investigators

  • Principal Investigator: Geoffrey Dervin, MD,MSc,FRCSC, OHRI / The Ottawa Hospital/ University of Ottawa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHREB 2009-240-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthropathy of Knee Joint

Clinical Trials on Total Knee Arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe