Cognition Following Computer Assisted Total Knee Arthropl... | NCT00830986

Studies
Cognition Following Computer Assisted Total Knee Arthroplasty

NCT00830986

Sponsor

Rothman Institute Orthopaedics

Status

Completed

Last Update Posted

Apr 16, 2009Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Cognition
Embolism, Fat

Interventions

Total Knee Arthroplasty Implant (Scorpio®)
Total Knee Arthroplasty Implant (Scorpio®)

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

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Jan 26, 2009

First Submission Date that Met QC Criteria

Jan 26, 2009

First Posted Date

Jan 28, 2009Estimated

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

Apr 14, 2009

Last Update Posted Date

Apr 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

A significant number of patients experience postoperative cognitive changes following total joint arthroplasty. Among other causes, the mental status change may be the result of fat and bone marrow debris embolization. We hypothesized that the use of computer assisted total knee arthroplasty, which does not utilize intramedullary alignment rods, would produce less fat and bone marrow debris embolization and, hence, fewer mental status changes.

Detailed Description

Inclusion criteria

Primary, cemented knee arthroplasty
Unilateral or bilateral TKA

Exclusion criteria

Patient is unable to speak English
Unable to read and write
Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
Patients with history of IV drug abuse
Previous history of dementia
Patients on mental status changing medications

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Computer Assisted Total Knee Arthroplasty	Device: Total Knee Arthroplasty Implant (Scorpio®)
2		Conventional Instrumented Total Knee Arthroplasty	Device: Total Knee Arthroplasty Implant (Scorpio®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total Knee Arthroplasty Implant (Scorpio®)	Device	Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Folstein Mini Mental State Examination (MMSE)		6 Months Post-Operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary, cemented knee arthroplasty
Unilateral or bilateral TKA

Exclusion Criteria:

Patient is unable to speak English
Unable to read and write
Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
Patients with history of IV drug abuse
Previous history of dementia
Patients on mental status changing medications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

100 Consecutive patients requiring a total knee arthroplasty for degenerative arthritis of the knee

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Javad Parvizi, MD, FRCS	Rothman Institute of Orthopaedics	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004620	Embolism, Fat

Ancestor Terms

ID	Term
D004617	Embolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided