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

Osteoarthritis, Knee Clinical Trial

Official title:

An Investigation of Computer-Assisted Total Knee Replacement Kinematics on Patient Performance: An Examination of the DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee and the DePuy P.F.C.® Sigma RP Rotating Platform Knee Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375856
• Other study ID #: DepuyRP06
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2006
• Last updated: September 26, 2016
• Start date: October 2006
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• DePuy P.F.C.® Sigma Rotating Platform Knee
no details

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Center	London	Ontario
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	DePuy Orthopaedics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait and radiographic parameters		0	No
Secondary	Knee pain, function		0	No