Obesity's Impact on the Effect of Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496716
• Other study ID #: THA-BMI
• Status: Completed
• Phase: N/A
• First received: December 19, 2011
• Last updated: August 12, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients recommended for primary total .

Exclusion Criteria:

• Rheumatoid arthritis.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Hip arthroplasty
The purpose of hip arthroplasties is to reduce pain and increase mobility.

Locations

Country	Name	City	State
Denmark	Department of Orthopedics Research Aarhus University Hospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36	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	No
Secondary	HOOS	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	No
Secondary	Body composition	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	No
Secondary	Bone mineral density (BMD).	Measured by DXA scan.	Measured 1 week before surgery and 12 months postoperatively	No