Arthropathy of Knee JointNCT00967161
Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis
A study testing Total Knee Arthroplasty and Motion analysis in people with Arthropathy of Knee Joint, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- Total Knee Arthroplasty and Motion analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
- Patients with any other joint replacement in the ipsilateral and contralateral limb.
- Patients with evidence of active infection.
- Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
- Patients with neuropathic joints.
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- Patients requiring structural bone grafts.
- Patients with a documented allergy to cobalt chromium molybdenum.
- Patient with a BMI larger than 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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
- Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
- Patients with any other joint replacement in the ipsilateral and contralateral limb.
- Patients with evidence of active infection.
- Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
- Patients with neuropathic joints.
- Patients requiring structural bone grafts.
- Patients with a documented allergy to cobalt chromium molybdenum.
- Patient with a BMI larger than 30 kg/m2.
- Conditions
- Arthropathy of Knee Joint
- Being tested
- Total Knee Arthroplasty, Motion analysis
- Keywords
- knee replacement motion analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Also called non applicable
Total Knee Arthroplasty
Motion analysisProcedure or surgery
Also called non applicable
Motion analysis (Gait/EMG during walking and functional tasks)
| Study group | Role | What they receive |
|---|---|---|
| Evolution Medial Pivot Knee | Experimental | 20 Patients will receive the EMP Knee Implant Receives: Procedure: Total Knee Arthroplasty; Procedure: Motion analysis |
| Triathlon PS Knee | Active comparator | 20 Patients will receive the Triathlon PS Knee Receives: Procedure: Total Knee Arthroplasty; Procedure: Motion analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The motion analysis assessments of the knee
Measured: pre-op,6,12 months following surgery
Secondary outcomes (1)
Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.
Measured: pre-op,6,12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of Knee JointStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Responsible party
- Sponsor
- Investigators
- Geoffrey Dervin, MD,MSc,FRCSC, Principal investigator, OHRI / The Ottawa Hospital/ University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967161
- Sponsor's protocol ID
- OHREB 2009-240-01H
- Status last verified
- Nov 2015
- First submitted
- 26 Aug 2009
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00967161
- Acronym / sponsor ID
- OHREB 2009-240-01H
- Conditions
- Arthropathy of Knee Joint
- Keywords
- knee replacement motion analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
- Patients with any other joint replacement in the ipsilateral and contralateral limb.
- Patients with evidence of active infection.
- Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
- Patients with neuropathic joints.
- Patients requiring structural bone grafts.
- Patients with a documented allergy to cobalt chromium molybdenum.
- Patient with a BMI larger than 30 kg/m2.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evolution Medial Pivot Knee | Experimental | Procedure: Total Knee Arthroplasty, Procedure: Motion analysis20 Patients will receive the EMP Knee Implant |
| Triathlon PS Knee | Active comparator | Procedure: Total Knee Arthroplasty, Procedure: Motion analysis20 Patients will receive the Triathlon PS Knee |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
- Patients with any other joint replacement in the ipsilateral and contralateral limb.
- Patients with evidence of active infection.
- Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastyAlso: non applicableTotal Knee Arthroplasty | Procedure or surgery | Evolution Medial Pivot Knee, Triathlon PS Knee |
| Motion analysisAlso: non applicableMotion analysis (Gait/EMG during walking and functional tasks) | Procedure or surgery | Evolution Medial Pivot Knee, Triathlon PS Knee |
Primary outcome
The motion analysis assessments of the knee
Time frame: pre-op,6,12 months following surgery
1 secondary outcome
Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.
Time frame: pre-op,6,12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Dervin, MD,MSc,FRCSC principal investigator
OHRI / The Ottawa Hospital/ University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty and Motion analysis in people with Arthropathy of Knee Joint, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The motion analysis assessments of the knee (time frame: pre-op,6,12 months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.