NCT01017341

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2 years

First QC Date

November 17, 2009

Last Update Submit

May 12, 2012

Conditions

Hip Fracture

Keywords

hip fractureback support

Outcome Measures

Primary Outcomes (1)

  • incidence of new hip fracture

    6 months, 1 ,2 and 3 yrs

Secondary Outcomes (1)

  • SF 36

    6 months, 1 ,2 and 3 yrs

Study Arms (1)

No hip protector

NO INTERVENTION

no hip protector

Device: PSU hip protector

Interventions

PSU hip protectorDEVICE

hip protetor

No hip protector

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with previous diagnosed as unilateral hip fracture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Boonsin Tangtrakulwanich, MD.,Ph.D.

    Department of Othropaedic Surgery, Faculty of Medicine, Prince of Songkla university, Hat Yai, Songkhla,Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Orthopaedic surgery

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 20, 2009

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

TH(1)