Computer-Assisted Total Knee Arthroplasty (TKA) With Zimmer LPS Flex Knee System

This study has been withdrawn prior to enrollment.
(problems with planned computer)
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00300326
First received: March 7, 2006
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Total Knee Arthroplasty for Knee Osteoarthritis
Device: LPS Flex knee system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigation of Total Knee Arthroplasty Kinematics on Patient Performance - The Zimmer Legacy® LPS Flex Knee System

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles) [ Time Frame: pre-op and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • knee pain, stiffness and function [ Time Frame: preop- 1 and 2 years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: January 2006
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
conventional surgery group
Device: LPS Flex knee system
flex knee system
Active Comparator: 2
computer-assist surgery group
Device: LPS Flex knee system
flex knee system

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300326

Sponsors and Collaborators
Queen's University
Zimmer, Inc.
Investigators
Principal Investigator: John Rudan, MD Queen's University
  More Information

No publications provided

Responsible Party: Dr. John Rudan, Queen's University
ClinicalTrials.gov Identifier: NCT00300326     History of Changes
Other Study ID Numbers: SURG-130-04
Study First Received: March 7, 2006
Last Updated: April 28, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014