Computer-Assisted Total Knee Replacement Kinematics: DePuy Sigma Posterior Cruciate Substituting Knee and the DePuy Sigma RP Rotating Platform Knee
NCT ID: NCT00375856
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2006-10-31
2012-12-31
Brief Summary
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1. Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e. quality of life, function, range of motion) than similar patients who undergo total knee arthroplasty (TKA) using the Sigma fixed bearing knee?
2. Do patients with knee OA who undergo TKA with a Sigma rotating platform have different knee kinetics and kinematics as measured by gait analysis than similar patients who undergo TKA using the Sigma fixed bearing knee?
3. Do patients with knee OA who undergo TKA with or without computer assistance have better clinical outcomes at two years following surgery (quality of life, function, range of motion)?
4. Do patients with knee OA who undergo TKA with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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1
DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee
No interventions assigned to this group
2
Rotating Platform Knee
DePuy P.F.C.® Sigma Rotating Platform Knee
no details
Interventions
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DePuy P.F.C.® Sigma Rotating Platform Knee
no details
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing primary total knee arthroplasty
* Clinically significant osteoarthritic degeneration
Exclusion Criteria
* Bilateral knee replacement (simultaneous)
* Previous joint infections
* Significant concurrent ipsilateral hip osteoarthritis
* Chronic pain syndrome requiring medications for control
* History of chemical addiction
* Significant spinal stenosis, significant symptomatic sciatica
* Patients who are unlikely to comply with, participate in, or return for follow-up visits as described in the protocol
* Osteomyelitis, septicemia or other infections that may spread to other areas of the body
* Highly communicable diseases, immuno-compromising conditions and/or conditions that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease)
* Decreased mental comprehension and literacy
* Prior high tibial osteotomy
* Prior patellectomy
* Rheumatoid arthritis
* Pregnancy
45 Years
75 Years
ALL
Yes
Sponsors
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DePuy Orthopaedics
INDUSTRY
Queen's University
OTHER
Responsible Party
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Dr. John Rudan
Principal Investigator
Principal Investigators
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John F Rudan, MD
Role: PRINCIPAL_INVESTIGATOR
Queen's University/Kingston General Hospital
Steve MacDonald, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Center
Eric Bohm, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba/Concordia Hospital
Locations
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University of Manitoba
Winnipeg, Manitoba, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
Countries
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Other Identifiers
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DepuyRP06
Identifier Type: -
Identifier Source: org_study_id
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