MedTrace Logo

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

NCT00375856 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2016-09-27

No results posted yet for this 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?

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

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

no details

Sponsors & Collaborators

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • Queen's University

    lead OTHER

Principal Investigators

  • John F Rudan, MD · Queen's University/Kingston General Hospital

  • Steve MacDonald, MD · London Health Sciences Center

  • Eric Bohm, MD · University of Manitoba/Concordia Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375856 on ClinicalTrials.gov