Obesity's Impact on the Effect of Hip Arthroplasty

August 12, 2013 updated by: University of Aarhus

Obesity's Impact on the Clinical Efficacy and Quality of Life 1 Year After Primary Total Hip Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Department of Orthopedics Research Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • All patients recommended for primary total .

Exclusion Criteria:

  • Rheumatoid arthritis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hip Osteoarthritis
Procedure: Hip arthroplasty
The purpose of hip arthroplasties is to reduce pain and increase mobility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36
Time Frame: Measured 1 week before surgery and 12 months postoperatively
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.
Measured 1 week before surgery and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOOS
Time Frame: Measured 1 week before surgery and 12 months postoperatively
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.
Measured 1 week before surgery and 12 months postoperatively
Body composition
Time Frame: Measured 1 week before surgery and 12 months postoperatively
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.
Measured 1 week before surgery and 12 months postoperatively
Bone mineral density (BMD).
Time Frame: Measured 1 week before surgery and 12 months postoperatively
Measured by DXA scan.
Measured 1 week before surgery and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Kjeld Søballe, professor, Department of Orthopedics Research Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THA-BMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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