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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stryker Trauma GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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