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

NCT ID: NCT00300326

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Using the same knee implant with a conventional surgical technique.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type: ACTIVE_COMPARATOR

Computer assist

Intervention Type: PROCEDURE

same implant using a computer-assisted surgical technique.

Interventions

Computer assist

same implant using a computer-assisted surgical technique.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. John Rudan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Rudan, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Other Identifiers

SURG-130-04

Identifier Type: -

Identifier Source: org_study_id