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CompletedNCT00375856Updated Sep 27, 2016

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

A Phase 4 interventional study of DePuy P.F.C.® Sigma Rotating Platform Knee in Osteoarthritis, Knee, sponsored by Queen's University. Completed at 3 sites in Canada. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by Queen's University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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?
02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • arthroplasty
  • knee
  • computer-assist
  • gait
  • Total knee arthroplasty
  • knee prostheses
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 91 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
91 participants (actual)

Study arms

  • 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

Interventions

  • DeviceDePuy P.F.C.® Sigma Rotating Platform Knee

    no details

    Also known as: no other name

06

What researchers measure

Primary outcomes

  1. Gait and radiographic parameters

    Time frame: 0

Secondary outcomes

  1. Knee pain, function

    Time frame: 0

07

Study locations

3 sites
  • University of Manitoba
    Winnipeg, Manitoba R2K 3S8, Canada
  • Kingston General Hospital
    Kingston, Ontario, Canada
  • London Health Sciences Center
    London, Ontario N6A 5A5, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2006, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2006
First posted
Sep 13, 2006
Start
Oct 2006
Primary completionActual
Dec 2012
CompletionActual
Dec 2012
Last update
Sep 27, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00375856
Lead sponsor
Queen's University
Collaborators
DePuy Orthopaedics
Responsible party
Dr. John Rudan (Principal Investigator, Queen's University) — Principal investigator
First posted
Sep 13, 2006
Start date
Oct 2006
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Sep 27, 2016

Study contacts

John F Rudan, MD
principal investigator · Queen's University/Kingston General Hospital
Steve MacDonald, MD
principal investigator · London Health Sciences Center
Eric Bohm, MD
principal investigator · University of Manitoba/Concordia Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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