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

NCT00300326 | Terminated Phase 4 DMC

• 1 other identifier: SURG-130-04
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

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

  pre-op and 1 year

Secondary Outcomes (1)

• knee pain, stiffness and function

  preop- 1 and 2 years

Study Arms (2)

1

NO INTERVENTION

Using the same knee implant with a conventional surgical technique.

2

ACTIVE COMPARATOR

Using the same knee implant using a computer-assist surgery group is the comparator

Procedure: Computer assist

Interventions

Computer assist PROCEDURE

same implant using a computer-assisted surgical technique.

2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead
• Zimmer Biomet: collaborator

Study Officials

• John Rudan, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: January 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: January 1, 2012
• Last Updated: September 27, 2016

Record last verified: 2009-04