Back to resultsHip Protector for Prevention of Hip Fracture
Primary Purpose
Hip Fracture
Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
PSU hip protector
Sponsored by
About this trial
This is an interventional prevention trial for Hip Fracture focused on measuring hip fracture, back support
Eligibility Criteria
Inclusion Criteria:
- Patients with previous diagnosed as unilateral hip fracture
Exclusion Criteria:
- Poor communicative ability
- Cannot independently ambulate
- Local skin problem at trocahnteric area
Sites / Locations
- Prince of Songkla University
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
No hip protector
Arm Description
no hip protector
Outcomes
Primary Outcome Measures
incidence of new hip fracture
Secondary Outcome Measures
SF 36
Full Information
NCT ID
NCT01017341
First Posted
November 17, 2009
Last Updated
May 12, 2012
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01017341
Brief Title
Hip Protector for Prevention of Hip Fracture
Official Title
PSU Hip Protector for Prevention of Hip Fracture From Falling
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
hip fracture, back support
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No hip protector
Arm Type
No Intervention
Arm Description
no hip protector
Intervention Type
Device
Intervention Name(s)
PSU hip protector
Intervention Description
hip protetor
Primary Outcome Measure Information:
Title
incidence of new hip fracture
Time Frame
6 months, 1 ,2 and 3 yrs
Secondary Outcome Measure Information:
Title
SF 36
Time Frame
6 months, 1 ,2 and 3 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with previous diagnosed as unilateral hip fracture
Exclusion Criteria:
Poor communicative ability
Cannot independently ambulate
Local skin problem at trocahnteric area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonsin Tangtrakulwanich, MD.,Ph.D.
Organizational Affiliation
Department of Othropaedic Surgery, Faculty of Medicine, Prince of Songkla university, Hat Yai, Songkhla,Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
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Hip Protector for Prevention of Hip Fracture
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