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Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

This study has been completed.
Sponsor:
Information provided by:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01079468
First received: March 1, 2010
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  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
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:

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079468

Locations
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
  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
Study First Received: March 1, 2010
Last Updated: November 7, 2011

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

ClinicalTrials.gov processed this record on July 21, 2017