Hip Protector for Prevention of Hip Fracture

May 12, 2012 updated by: Boonsin Tangtrakulwanich, Prince of Songkla University

PSU Hip Protector for Prevention of Hip Fracture From Falling

This study aims to evaluate the efficacy of the investigators PSU hip protector for prevention of fracture in elderly.The eligible patients include those with previous diagnosed as unilateral hip fracture. They will be randomized into 2 groups;psu hip protector and no protector. The patients will be instructed to wear the protector fulltime.The inceidence of hip fracture will be compared between both group at the end of 1 year.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

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

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Prince of Songkla University

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with previous diagnosed as unilateral hip fracture

Exclusion Criteria:

  • Poor communicative ability
  • Cannot independently ambulate
  • Local skin problem at trocahnteric area

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No hip protector
no hip protector
Device: PSU hip protector
hip protetor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of new hip fracture
Time Frame: 6 months, 1 ,2 and 3 yrs
6 months, 1 ,2 and 3 yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
SF 36
Time Frame: 6 months, 1 ,2 and 3 yrs
6 months, 1 ,2 and 3 yrs

Collaborators and Investigators

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

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D., Department of Othropaedic Surgery, Faculty of Medicine, Prince of Songkla university, Hat Yai, Songkhla,Thailand

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

June 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 20, 2009

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 12, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC52-169-11-4-2

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.

Clinical Trials on Hip Fracture

Clinical Trials on PSU hip protector

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe