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

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring arthroplasty, knee, computer-assist, gait, Total knee arthroplasty, knee prostheses

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Manitoba
Kingston General Hospital
London Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

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

Rotating Platform Knee

Outcomes

Primary Outcome Measures

Gait and radiographic parameters

Secondary Outcome Measures

Knee pain, function

Full Information

NCT ID

NCT00375856

First Posted

September 12, 2006

Last Updated

September 26, 2016

Sponsor

Queen's University

Collaborators

DePuy Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT00375856

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

Collaborators

DePuy Orthopaedics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Research Questions: 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? 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? 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)? Do patients with knee OA who undergo TKA with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

arthroplasty, knee, computer-assist, gait, Total knee arthroplasty, knee prostheses

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

Rotating Platform Knee

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

no other name

Intervention Description

no details

Primary Outcome Measure Information:

Title

Gait and radiographic parameters

Time Frame

Secondary Outcome Measure Information:

Title

Knee pain, function

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John F Rudan, MD

Organizational Affiliation

Queen's University/Kingston General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steve MacDonald, MD

Organizational Affiliation

London Health Sciences Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eric Bohm, MD

Organizational Affiliation

University of Manitoba/Concordia Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2K 3S8

Country

Canada

Facility Name

Kingston General Hospital

City

Kingston

State/Province

Ontario

Country

Canada

Facility Name

London Health Sciences Center

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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