Hip Protector for Prevention of Hip Fracture

Hip Fracture Clinical Trial

Official title:

PSU Hip Protector for Prevention of Hip Fracture From Falling

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01017341
• Other study ID #: EC52-169-11-4-2
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 17, 2009
• Last updated: May 12, 2012
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2012
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Device:
• PSU hip protector
hip protetor

Locations

Country	Name	City	State
Thailand	Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of new hip fracture		6 months, 1 ,2 and 3 yrs	No
Secondary	SF 36		6 months, 1 ,2 and 3 yrs	No