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

Phase 4

Terminated

• Conditions: Knee Arthroplasty
• Interventions: Procedure: Computer assist

• Registration Number: NCT00300326
• Lead Sponsor: Queen's University

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-08
• Status Verified: 2009-04
• Primary Completion: 2011-04
• Study Completion: 2012-01
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Computer assist	Using the same knee implant using a computer-assist surgery group is the comparator

Primary Outcome Measures

Name	Time	Method
Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles)	pre-op and 1 year

Secondary Outcome Measures

Name	Time	Method
knee pain, stiffness and function	preop- 1 and 2 years