CClinicalTrials.gg
TerminatedNCT00300326Updated Sep 27, 2016

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

A Phase 4 interventional study of Computer assist in Knee Arthroplasty, sponsored by Queen's University. Terminated. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by Queen's University · Phase 4, Interventional, and Treatment

Why this study was terminated
problems with planned computer
Phase
Phase 4
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Arthroplasty
03

In context

Lead sponsor

Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureComputer assist

    same implant using a computer-assisted surgical technique.

06

What researchers measure

Primary outcomes

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

    Time frame: pre-op and 1 year

Secondary outcomes

  1. knee pain, stiffness and function

    Time frame: preop- 1 and 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00300326
Lead sponsor
Queen's University
Collaborators
Zimmer Biomet
Responsible party
Dr. John Rudan (Principal Investigator, Queen's University) — Principal investigator
First posted
Mar 8, 2006
Start date
Jan 2006
Primary completion
Apr 2011
Completion
Jan 2012
Last update
Sep 27, 2016

Study contacts

John Rudan, MD
principal investigator · Queen's University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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