NCT00375856

Brief Summary

Primary Research Questions:

  1. 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. 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. 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 27, 2016

Status Verified

May 1, 2013

Enrollment Period

6.2 years

First QC Date

September 12, 2006

Last Update Submit

September 26, 2016

Conditions

Osteoarthritis, Knee

Keywords

arthroplastykneecomputer-assistgaitTotal knee arthroplastyknee prostheses

Outcome Measures

Primary Outcomes (1)

  • Gait and radiographic parameters

    0

Secondary Outcomes (1)

  • Knee pain, function

    0

Study Arms (2)

1

NO INTERVENTION

DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee

2

EXPERIMENTAL

Rotating Platform Knee

Device: DePuy P.F.C.® Sigma Rotating Platform Knee

Interventions

DePuy P.F.C.® Sigma Rotating Platform KneeDEVICE

no details

Also known as: no other name
2

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Manitoba

Winnipeg, Manitoba, R2K 3S8, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 27, 2016

Record last verified: 2013-05

Locations

CA(3)