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Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01079468

First Posted: March 3, 2010

Last Update Posted: November 8, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Rothman Institute Orthopaedics

Purpose

Transient cognitive changes after surgery may be due to many different factors. It is estimated that between 5-29% of patients undergoing orthopedic surgery experience a transient decline in their cognition. Fat and bone marrow debris embolization can cause cognitive changes if they enter the cerebral circulation in significant numbers. During total hip arthroplasty the placement of the femoral stem leads to a rise in intramedullary pressure which can cause fat and bone marrow debris to embolize into the systemic circulation. Total hip resurfacing arthroplasty avoids entrance into the femoral canal. The purpose of this study is to assess transient cognitive changes after total hip arthroplasty and compare them to patients undergoing total hip resurfacing arthroplasty. We hypothesize that patients undergoing total hip resurfacing arthroplasty will experience less transient cognitive changes due to the avoidance of violating the femoral canal during the procedure.

Condition
Cognition


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:

Degree of transient cognitive changes postoperatively as measured by the Folstein mini-mental examination

Secondary Outcome Measures:

Percentage of patient who experience transient cognitive decline following Total Hip Arthroplasty or total hip resurfacing arthroplasty as measured by the Folstein mini-mental examination


Estimated Enrollment:	100
Study Start Date:	January 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Total Hip Arthroplasty
Total Hip Resurfacing Arthroplasty

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients undergoing either Total Hip Arthroplasty or Total Hip Resurfacing Arhtroplasty at our Institution

Criteria

Inclusion Criteria:

Male and non-pregnant, non-lactating, female subjects who are 18 and older
Subjects who are able and willing to provide informed consent
Subjects deemed able to comply with study schedule visits and procedures
Subjects undergoing elective THA procedures
Subjects undergoing elective total hip resurfacing arthroplasty
Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.

Exclusion Criteria:

Subjects with or with a history of Parkinson's Disease
Subjects with a history of depression as reported in their past medical history
Subjects with a history of dementia as reported in their past medical history
Subjects currently using antidepressants
Subjects currently using antipsychotic medications

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079468

Locations


United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

More Information

Publications:

Koch S, Forteza A, Lavernia C, Romano JG, Campo-Bustillo I, Campo N, Gold S. Cerebral fat microembolism and cognitive decline after hip and knee replacement. Stroke. 2007 Mar;38(3):1079-81. Epub 2007 Jan 25.

Koessler MJ, Pitto RP. Fat embolism and cerebral function in total hip arthroplasty. Int Orthop. 2002;26(5):259-62. Epub 2002 Jun 25. Review.


Responsible Party:	William Hozack, MD, Prinicple Investigator, Rothman Institute
ClinicalTrials.gov Identifier:	NCT01079468 History of Changes
Other Study ID Numbers:	RIUHOZ 10-01
First Submitted:	March 1, 2010
First Posted:	March 3, 2010
Last Update Posted:	November 8, 2011
Last Verified:	November 2011

Keywords provided by Rothman Institute Orthopaedics:


Transient cognitive decline following orthopaedic surgery

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