Status:

COMPLETED

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

Lead Sponsor:

Queen's University

Collaborating Sponsors:

DePuy Orthopaedics

Conditions:

Osteoarthritis, Knee

Eligibility:

All Genders

45-75 years

Phase:

PHASE4

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. ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

91 Patients enrolled

Trial Details

Trial ID

NCT00375856

Start Date

October 1 2006

End Date

December 1 2012

Last Update

September 27 2016

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Manitoba

Winnipeg, Manitoba, Canada, R2K 3S8

2

Kingston General Hospital

Kingston, Ontario, Canada

3

London Health Sciences Center

London, Ontario, Canada, N6A 5A5