Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

NCT01079468 | Completed

• 1 other identifier: RIUHOZ 10-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition

Keywords

Transient cognitive decline following orthopaedic surgery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Study Arms (2)

Total Hip Arthroplasty

Total Hip Resurfacing Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related 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. doi: 10.1161/01.STR.0000258104.01627.50. Epub 2007 Jan 25.

  PMID: 17255544 BACKGROUND

• Koessler MJ, Pitto RP. Fat embolism and cerebral function in total hip arthroplasty. Int Orthop. 2002;26(5):259-62. doi: 10.1007/s00264-002-0380-2. Epub 2002 Jun 25. No abstract available.

  PMID: 12378348 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

US (1)