Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

Cognition Clinical Trial

Official title:

Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079468
• Other study ID #: RIUHOZ 10-01
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: November 7, 2011
• Start date: January 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of transient cognitive changes postoperatively as measured by the Folstein mini-mental examination
Secondary	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