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

Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00300326
• Other study ID #: SURG-130-04
• Status: Terminated
• Phase: Phase 4
• First received: March 7, 2006
• Last updated: September 26, 2016
• Start date: January 2006
• Est. completion date: January 2012

Study information

• Verified date: April 2009
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Procedure:
• Computer assist
same implant using a computer-assisted surgical technique.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Zimmer, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles)		pre-op and 1 year	No
Secondary	knee pain, stiffness and function		preop- 1 and 2 years	No