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Clinical Trials/NCT00300326
NCT00300326
Terminated
Phase 4

An Investigation of Total Knee Arthroplasty Kinematics on Patient Performance - The Zimmer Legacy® LPS Flex Knee System

Queen's University0 sites7 target enrollmentJanuary 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Knee Arthroplasty
Sponsor
Queen's University
Enrollment
7
Primary Endpoint
Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles)
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
January 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. John Rudan

Principal Investigator

Queen's University

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

Outcomes

Primary Outcomes

Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles)

Time Frame: pre-op and 1 year

Secondary Outcomes

  • knee pain, stiffness and function(preop- 1 and 2 years)

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