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OpenTrials
Completed

NCT Number: NCT01079468

Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

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.

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Key information

Conditions

Cognition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 3, 2010
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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