Computer-assisted Total Knee Arthroplasty (TKA) With Zimm... | NCT00300326

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

NCT00300326

Sponsor

Queen's University

Status

Terminated

Last Update Posted

Sep 27, 2016Estimated

Enrollment

7Actual

Phase

Phase 4

Conditions

Knee Arthroplasty

Interventions

Computer assist

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

problems with planned computer

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Apr 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Mar 7, 2006

First Submission Date that Met QC Criteria

Mar 7, 2006

First Posted Date

Mar 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Name	Class
Zimmer Biomet	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Computer assist	Procedure	same implant using a computer-assisted surgical technique.	2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
knee pain, stiffness and function		preop- 1 and 2 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided