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

September 26, 2016 updated by: Dr. John Rudan, Queen's University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles)
Time Frame: pre-op and 1 year
pre-op and 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
knee pain, stiffness and function
Time Frame: preop- 1 and 2 years
preop- 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: John Rudan, MD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 7, 2006

First Posted (Estimate)

March 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

April 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • SURG-130-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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