Clinical trial NCT00300326: Computer-assisted Total Knee Arthroplasty (TKA) With Zimmer LPS Flex Knee System
Official title: An Investigation of Total Knee Arthroplasty Kinematics on Patient Performance - The Zimmer Legacy® LPS Flex Knee System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Knee Arthroplasty
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2006-03-08
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine clinical outcomes and biomechanical gait performance of patients who receive the Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. This study will provide evidence as to whether there are differences between the two surgical procedures with respect to complications such as infection and dislocations, rate and level of functional recovery, blood loss, operating time, degree of radiographic correction and quality and duration of post-operative pain and stiffness.

Detailed description: The objective of this study is to determine the clinical outcomes and biomechanical gait performance of patients who receive the Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. Pre and post-operative clinical and gait variables will be compared within the computer-assisted group. These same comparisons will also be made between the computer-assisted surgical group and a conventional surgical group who receive the same knee implant. This study will further provide evidence as to whether there are differences between the two surgical procedures with respect to complications such as infection and dislocations, rate and level of functional recovery, blood loss, operating time, degree of radiographic correction and quality and duration of post-operative pain and stiffness.

Eligibility criteria: Inclusion Criteria:

* age 50-80

  * undergoing primary total knee arthroplasty
  * femoral tibial varus \< 7 degrees
  * no previous joint infections
  * anteriorcruciate ligament intact
  * clinically significant patellofemoral or osteoarthritic degeneration

Exclusion Criteria:

* active articular infections
* significant concurrent ipsilateral hip osteoarthritis
* chronic pain syndrome requiring medications for control
* history of chemical addiction
* significant spinal stenosis, chronic back pain, 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 that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease)
* diabetic neuropathy
* skeletal immaturity
* decreased mental comprehension and literacy
* pregnancy

Primary outcomes:
measure: Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles)
timeFrame: pre-op and 1 year
Secondary outcomes:
measure: knee pain, stiffness and function
timeFrame: preop- 1 and 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Queen's University
name: John Rudan, MD
role: PRINCIPAL_INVESTIGATOR
References: