Clinical trial NCT00375856: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: arthroplasty
knee
computer-assist
gait
Total knee arthroplasty
knee prostheses
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2006-09-13
Enrollment: 91
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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?


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

Primary outcomes:
measure: Gait and radiographic parameters
timeFrame: 0
Secondary outcomes:
measure: Knee pain, function
timeFrame: 0
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: Queen's University/Kingston General Hospital
name: John F Rudan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Center
name: Steve MacDonald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba/Concordia Hospital
name: Eric Bohm, MD
role: PRINCIPAL_INVESTIGATOR
References: