MedDataX Logo

Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

NCT ID: NCT01079468

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Total Hip Arthroplasty

No interventions assigned to this group

Total Hip Resurfacing Arthroplasty

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rothman Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17255544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12378348 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RIUHOZ 10-01

Identifier Type: -

Identifier Source: org_study_id