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Epidemiology Study in Major Orthopaedic Surgery

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Hoersholm Hospital
ClinicalTrials.gov Identifier:
NCT00159185
First received: September 9, 2005
Last updated: July 20, 2006
Last verified: September 2005
History of Changes
  Purpose

The purpose of this study is to:

  • Create a database including a description of the patient population that undergoes total hip replacement with special emphasis on orthopedic and cardiovascular complications and the quality of life 1 year postoperatively.
  • Characterise the patient at risk for the above mentioned events
  • Create methods for predicting patients at risk for short-term (90 days) and long term (1 year) complications in relation to hip replacement surgery.

Condition
Thrombosis
Postoperative Complications
Quality of Life

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Epidemiology Study in Major Orthopaedic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Further study details as provided by Hoersholm Hospital:

Estimated Enrollment: 500
Study Start Date: January 2004
Estimated Study Completion Date: May 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients operated with Hip Arthroplasty Replacement in Hillerød and Hørsholm Hospitals from 1.1 2004.

Exclusion Criteria:

  • Written informed consent denied
  • Patients under 18 years of age.
  • Patients not habitants of Denmark at the time of the operation.
  • Patients without a CPR-number (civil registration number).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159185

Locations
Denmark
Hoersholm Hospital
Hoersholm, Denmark, 2970
Sponsors and Collaborators
Hoersholm Hospital
GlaxoSmithKline
Investigators
Study Chair: Camilla Ryge, MD Hoersholm Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159185     History of Changes
Other Study ID Numbers: ESMOS
Study First Received: September 9, 2005
Last Updated: July 20, 2006
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Hoersholm Hospital:
Arthroplasty, Replacement, Hip
Epidemiology

Additional relevant MeSH terms:
Postoperative Complications
Thrombosis
Pathologic Processes
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013