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Computer-Assisted Total Knee Replacement Kinematics: DePuy Sigma Posterior Cruciate Substituting Knee and the DePuy Sigma RP Rotating Platform Knee

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ClinicalTrials.gov Identifier: NCT00375856
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Primary Research Questions:

  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?

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: DePuy P.F.C.® Sigma Rotating Platform Knee Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Investigation of Computer-Assisted Total Knee Replacement Kinematics on Patient Performance: An Examination of the DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee and the DePuy P.F.C.® Sigma RP Rotating Platform Knee Systems
Study Start Date : October 2006
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee
Experimental: 2
Rotating Platform Knee
Device: DePuy P.F.C.® Sigma Rotating Platform Knee
no details
Other Name: no other name


Outcome Measures

Primary Outcome Measures :
  1. Gait and radiographic parameters [ Time Frame: 0 ]

Secondary Outcome Measures :
  1. Knee pain, function [ Time Frame: 0 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 45-75 years
  • Undergoing primary total knee arthroplasty
  • Clinically significant osteoarthritic degeneration

Exclusion Criteria:

  • Active articular infections
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375856


Locations
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R2K 3S8
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Queen's University
DePuy Orthopaedics
Investigators
Principal Investigator: John F Rudan, MD Queen's University/Kingston General Hospital
Principal Investigator: Steve MacDonald, MD London Health Sciences Center
Principal Investigator: Eric Bohm, MD University of Manitoba/Concordia Hospital
More Information

Responsible Party: Dr. John Rudan, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00375856     History of Changes
Other Study ID Numbers: DepuyRP06
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: May 2013

Keywords provided by Dr. John Rudan, Queen's University:
arthroplasty
knee
computer-assist
gait
Total knee arthroplasty
knee prostheses

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