NCT01496716

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

1.5 years

First QC Date

December 19, 2011

Last Update Submit

August 12, 2013

Conditions

Hip Osteoarthritis

Keywords

Osteoarthritisobesityquality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • HOOS

    Measured 1 week before surgery and 12 months postoperatively

  • Body composition

    Measured 1 week before surgery and 12 months postoperatively

  • Bone mineral density (BMD).

    Measured 1 week before surgery and 12 months postoperatively

Study Arms (1)

Hip Osteoarthritis

Procedure: Hip arthroplasty

Interventions

Hip arthroplastyPROCEDURE

The purpose of hip arthroplasties is to reduce pain and increase mobility.

Hip Osteoarthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • All patients recommended for primary total .

You may not qualify if:

  • Rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedics Research Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritisObesity

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Kjeld Søballe, professor

    Department of Orthopedics Research Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

DK(1)