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

September 12, 2006
May 15, 2013
October 2006
December 2012   (final data collection date for primary outcome measure)
Gait and radiographic parameters [ Time Frame: 0 ] [ Designated as safety issue: No ]
Gait and radiographic parameters.
Complete list of historical versions of study NCT00375856 on ClinicalTrials.gov Archive Site
Knee pain, function [ Time Frame: 0 ] [ Designated as safety issue: No ]
Knee pain, function
Not Provided
Not Provided
 
Computer-Assisted Total Knee Replacement Kinematics: DePuy Sigma Posterior Cruciate Substituting Knee and the DePuy Sigma RP Rotating Platform Knee
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

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?
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Osteoarthritis, Knee
Device: DePuy P.F.C.® Sigma Rotating Platform Knee
no details
Other Name: no other name
  • No Intervention: 1
    DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee
  • Experimental: 2
    Rotating Platform Knee
    Intervention: Device: DePuy P.F.C.® Sigma Rotating Platform Knee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00375856
DepuyRP06
Yes
Queen's University
Queen's University
DePuy Orthopaedics
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
Queen's University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP