ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

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.
ClinicalTrials.gov Identifier: NCT01079468
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : November 8, 2011
Sponsor:
Information provided by:
Rothman Institute Orthopaedics

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Cognition

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients
Study Start Date : January 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Total Hip Arthroplasty
Total Hip Resurfacing Arthroplasty


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Degree of transient cognitive changes postoperatively as measured by the Folstein mini-mental examination

Secondary Outcome Measures :
  1. 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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:

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

Exclusion Criteria:

  1. Subjects with or with a history of Parkinson's Disease
  2. Subjects with a history of depression as reported in their past medical history
  3. Subjects with a history of dementia as reported in their past medical history
  4. Subjects currently using antidepressants
  5. Subjects currently using antipsychotic medications
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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

Keywords provided by Rothman Institute Orthopaedics:
Transient cognitive decline following orthopaedic surgery