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Hip Protector for Prevention of Hip Fracture

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Boonsin Tangtrakulwanich, Prince of Songkla University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017341
First Posted: November 20, 2009
Last Update Posted: May 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University
  Purpose
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.

Condition Intervention Phase
Hip Fracture Device: PSU hip protector Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: PSU Hip Protector for Prevention of Hip Fracture From Falling

Resource links provided by NLM:


Further study details as provided by Boonsin Tangtrakulwanich, Prince of Songkla University:

Primary Outcome Measures:
  • incidence of new hip fracture [ Time Frame: 6 months, 1 ,2 and 3 yrs ]

Secondary Outcome Measures:
  • SF 36 [ Time Frame: 6 months, 1 ,2 and 3 yrs ]

Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No hip protector
no hip protector
Device: PSU hip protector
hip protetor

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017341


Locations
Thailand
Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
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
  More Information

Responsible Party: Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017341     History of Changes
Other Study ID Numbers: EC52-169-11-4-2
First Submitted: November 17, 2009
First Posted: November 20, 2009
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Boonsin Tangtrakulwanich, Prince of Songkla University:
hip fracture
back support

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries