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

This study has been completed.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT00375856
First received: September 12, 2006
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis, Knee
 Device: DePuy P.F.C.® Sigma Rotating Platform Knee
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Gait and radiographic parameters [ Time Frame: 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knee pain, function [ Time Frame: 0 ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: October 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT00375856     History of Changes
Other Study ID Numbers: DepuyRP06
Study First Received: September 12, 2006
Last Updated: May 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013