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Hip protectors: recommendations for conducting clinical trials—an international consensus statement (part II)

  • I. D. CameronEmail author
  • S. Robinovitch
  • S. Birge
  • P. Kannus
  • K. Khan
  • J. Lauritzen
  • J. Howland
  • S. Evans
  • J. Minns
  • A. Laing
  • P. Cripton
  • S. Derler
  • D. Plant
  • D. P. Kiel
Consensus Statement

Abstract

Introduction

While hip protectors are effective in some clinical trials, many, including all in community settings, have been unable to demonstrate effectiveness. This is due partly to differences in the design and analysis. The aim of this report is to develop recommendations for subsequent clinical research.

Methods

In November of 2007, the International Hip Protector Research Group met to address barriers to the clinical effectiveness of hip protectors. This paper represents a consensus statement from the group on recommended methods for conducting future clinical trials of hip protectors.

Results and conclusions

Consensus recommendations include the following: the use of a hip protector that has undergone adequate biomechanical testing, the use of sham hip protectors, the conduct of clinical trials in populations with annual hip fracture incidence of at least 3%, a run-in period with demonstration of adequate adherence, surveillance of falls and adherence, and the inclusion of economic analyses. Larger and more costly clinical trials are required to definitively investigate effectiveness of hip protectors.

Keywords

Aged Clinical trial Hip fractures Nursing home Materials testing 

Notes

Acknowledgments

This research was supported in part by the Canadian Institutes for Health Research (CIHR) through a Planning/Development Grant from the International Opportunities Program (P.I.: Robinovitch). Dr. Kiel and Birge were supported by a grant from the National Institute on Aging R01 AG18461. Dr. Kannus was supported by Competitive Research Funding of the Pirkanmaa Hospital District, Tampere, Finland.

The authors acknowledge the assistance of Dr Bruce Barton and Dr Jennifer Davis in revising this paper.

Conflicts of interest

S.N. Robinovitch is a paid consultant to Tytex A/S, manufacturer of the Safehip line of wearable hip protectors.

S.J. Birge has served on speakers' bureaus for Merck, Novartis, Wyeth and as a consultant to Glaxo-Smith Kline and Pfizer.

P. Kannus has received grant funding, lecturing fees, or consulting fees from Aventis, MSD, Novartis, Pfizer, Respecta, and Roche.

J.B. Lauritzen has been a paid consultant to Tytex A/S until 2006.

S.L. Evans is was a consultant to the Ascent Group on hip protector design and testing and is currently a consultant to Dow Corning on impact protection materials and testing.

R.J. Minns received financial assistance from WinHealth (the European distributors of HipSaver hip protectors) for the construction of the test rig in his laboratory.

A.C. Laing has received funding for conference travel from Tytex A/S.

D.P. Kiel has received grants, served on advisory boards, or served on speakers’ bureaus for Eli Lilly, Novartis, Merck, Procter and Gamble, Amgen, GSK, Pfizer, Lifeline, and Hologic.

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Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2009

Authors and Affiliations

  • I. D. Cameron
    • 1
    Email author
  • S. Robinovitch
    • 2
  • S. Birge
    • 3
  • P. Kannus
    • 4
  • K. Khan
    • 5
  • J. Lauritzen
    • 6
  • J. Howland
    • 7
  • S. Evans
    • 8
  • J. Minns
    • 9
  • A. Laing
    • 10
  • P. Cripton
    • 11
  • S. Derler
    • 12
  • D. Plant
    • 13
  • D. P. Kiel
    • 14
  1. 1.Rehabilitation Studies UnitUniversity of SydneySydneyAustralia
  2. 2.School of Engineering Science and Department of Biomedical Physiology and KinesiologySimon Fraser UniversityVancouverCanada
  3. 3.Division of Geriatrics and Nutritional Science, School of MedicineWashington UniversitySt. LouisUSA
  4. 4.Injury and Osteoporosis Research CenterUKK InstituteTampereFinland
  5. 5.Centre for Hip Health and Mobility, Faculty of MedicineUniversity of British ColumbiaVancouverCanada
  6. 6.Department of Orthopedics & Internal Medicine, Bispebjerg HospitalUniversity of CopenhagenCopenhagenDenmark
  7. 7.Social and Behavioral Sciences DepartmentBoston UniversityBostonUSA
  8. 8.School of EngineeringCardiff UniversityCardiffUK
  9. 9.National Health ServiceNewcastle upon TyneUK
  10. 10.Department of OrthopaedicsUniversity of British ColumbiaVancouverCanada
  11. 11.Department of Mechanical EngineeringUniversity of British ColumbiaVancouverCanada
  12. 12.Laboratory for Protection and PhysiologySwiss Federal Laboratories for Materials Testing and Research (Empa)St. GallenSwitzerland
  13. 13.Mechanics of Materials Group, Mechanical EngineeringImperial CollegeLondonUK
  14. 14.Institute for Aging ResearchHebrew Senior LifeBostonUSA

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