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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00375856

Enrollment

Registered

2006-09-13

Start date

2006-10-31

Completion date

2012-12-31

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

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

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?

Interventions

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

no details

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Gait and radiographic parameters	0

Secondary

Measure	Time frame
Knee pain, function	0

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026