We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(problems with planned computer)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300326
First Posted: March 8, 2006
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Dr. John Rudan, Queen's University
  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
Knee Arthroplasty Procedure: Computer assist Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Dr. John Rudan, 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 ]

Secondary Outcome Measures:
  • knee pain, stiffness and function [ Time Frame: preop- 1 and 2 years ]

Enrollment: 7
Study Start Date: January 2006
Study Completion Date: January 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Using the same knee implant with a conventional surgical technique.
Active Comparator: 2
Using the same knee implant using a computer-assist surgery group is the comparator
Procedure: Computer assist
same implant using a computer-assisted surgical technique.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300326


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

Responsible Party: Dr. John Rudan, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00300326     History of Changes
Other Study ID Numbers: SURG-130-04
First Submitted: March 7, 2006
First Posted: March 8, 2006
Last Update Posted: September 27, 2016
Last Verified: April 2009