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

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: DePuy P.F.C.® Sigma Rotating Platform Knee

• Registration Number: NCT00375856
• Lead Sponsor: Queen's University

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. 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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-12
• Study First Submitted QC: 2006-09-12
• Study First Posted: 2006-09-13
• Study Start: 2006-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	DePuy P.F.C.® Sigma Rotating Platform Knee	Rotating Platform Knee

Primary Outcome Measures

Name	Time	Method
Gait and radiographic parameters	0

Secondary Outcome Measures

Name	Time	Method
Knee pain, function	0

Trial Locations

Locations (3)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences Center; 🇨🇦 London, Ontario, Canada

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada