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Obesity's Impact on the Effect of Hip Arthroplasty

This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01496716
First received: December 19, 2011
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to investigate whether there is a correlation between hip arthroplasty patients' preoperative weight and the patients quality of life and the clinical effect one year postoperatively.


Condition Intervention
Hip Osteoarthritis
 Procedure: Hip arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Obesity's Impact on the Clinical Efficacy and Quality of Life 1 Year After Primary Total Hip Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • SF-36 [ Time Frame: Measured 1 week before surgery and 12 months postoperatively ] [ Designated as safety issue: No ]
    A patient reported outcome (PRO). The questionnaire is a tool for measuring health status. The form is used to measure the patient's view of his own health by scoring standardized responses to standardized questions. The schedule consists of 36 questions representing eight health concepts.


Secondary Outcome Measures:
  • HOOS [ Time Frame: Measured 1 week before surgery and 12 months postoperatively ] [ Designated as safety issue: No ]
    Hip - specific patient-reported outcome that measures the patient's own assessment of hip problems and related problems. The schedule consists of 42 questions representing 5 strands.

  • Body composition [ Time Frame: Measured 1 week before surgery and 12 months postoperatively ] [ Designated as safety issue: No ]
    Dual energy X-ray absorptiometry (DEXA) can measure total body bone mineral density and obtain accurate measurements of body tissue composition (muscle mass and fat mass). By measuring the body's muscle mass, fat mass and bone mineral density, one can estimate total body fat percentage.

  • Bone mineral density (BMD). [ Time Frame: Measured 1 week before surgery and 12 months postoperatively ] [ Designated as safety issue: No ]
    Measured by DXA scan.


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hip Osteoarthritis Procedure: Hip arthroplasty
The purpose of hip arthroplasties is to reduce pain and increase mobility.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All hip total hip replacement patients operated on Hospital Southern Jutland, Denmark.

Criteria

Inclusion Criteria:

  • All patients recommended for primary total .

Exclusion Criteria:

  • Rheumatoid arthritis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496716

Contacts
Contact: Anette Liljensøe, PhD stud. +45 2296 9301 anette.liljensoe@ki.au.dk

Locations
Denmark
Department of Orthopedics Research Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Anette Liljensøe, PhD-student     +45 2296 9301     anette.liljensoe@ki.au.dk    
Principal Investigator: Anette Liljensøe, PhD-student            
Principal Investigator: Inger Mechlenburg, Assoc. Prof.            
Principal Investigator: Jens Ole Laursen, MD            
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Kjeld Søballe, professor Department of Orthopedics Research Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01496716     History of Changes
Other Study ID Numbers: THA-BMI
Study First Received: December 19, 2011
Last Updated: November 1, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Osteoarthritis
obesity
quality of life

Additional relevant MeSH terms:
Obesity
Osteoarthritis
Osteoarthritis, Hip
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013