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Hip Protector for Prevention of Hip Fracture

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01017341
First received: November 17, 2009
Last updated: May 12, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: PSU Hip Protector for Prevention of Hip Fracture From Falling

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • incidence of new hip fracture [ Time Frame: 6 months, 1 ,2 and 3 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF 36 [ Time Frame: 6 months, 1 ,2 and 3 yrs ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 17, 2009
Last Updated: May 12, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013