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

Queen's University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00375856

DepuyRP06

Details and patient eligibility

About

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?

Enrollment: 91 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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91 participants in 2 patient groups

1

No Intervention group

Description:

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

2

Experimental group

Description:

Rotating Platform Knee

Treatment:

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