Randomized controlled trial of hip protectors among women living in the community

Abstract

Objective: To asess whether hip protectors used among women living in the community in the United Kingdom and at high risk of hip fracture, lead to a reduction in hip fracture. Design: Pragmatic randomized controlled trial (RCT). Setting: Primary care with participants being recruited largely from general practitioners’ patient lists. Participants: Women aged 70 years and over with one or more risk factors for hip fracture (i.e., low body weight, current smoker, a prior fracture, family history of hip fracture). Intervention: Three pairs of hip protectors of the “shell” type mailed to participants with instructions on how to use them. Main outcome measure: Reduction in hip fractures. Results: 1,388 and 2,781 women aged 70 years or over were randomized to be given three pairs of hip protectors or act as controls, respectively. We followed up both groups of women for a minimum of 24 months (maximum 42 months, median 28). Compliance was poor with only 31% of participants reporting that they wore the hip protectors on a daily basis at 12 months. Intention-to-treat analysis showed that there was no statistically significant difference in the unadjusted odds ratios (ORs) of sustaining a hip fracture between the groups (OR=1.19; 95% confidence interval, 0.80 to 1.78, p=0.40). Adjustment for important covariates did not materially change these findings (OR=1.17; 95% CI, 0.78 to 1.75). Comparing the rate of hip fracture between those women who regularly wore the devices and the control group yielded an OR of 1.12 (95% CI, 0.58 to 2.03; p=0.83). Conclusion: This study is the largest RCT of hip protectors to date and provides no evidence of an effect of hip protectors among women living independently and at high risk of fracture.

Appendix: Members of the Primary Care Hip Protector Trial Group

Trial Coordinators: Dr Yvonne Birks, Research Fellow, Yorks Trial Unit, was the main trial coordinator based at York, UK. Jill Porthouse, Research Fellow, Yorks Trial Unit, was originally a local trial coordinator and then took over from Y.B. as main trial coordinator in York. Caroline Addie, Arthritis and Osteoporosis Resource Centre, Woolmanhill Hospital, Aberdeen; Karen Loughey, Bone Clinic, Freeman Hospital, Newcastle-upon-Tyne; and Lucy Saxon, Hertfordshire Primary Care Network, were local trial coordinators in Aberdeen, Newcastle, and Hertfordshire, respectively. All trial coordinators recruited GPs; participants undertook data entry and verification.

Support staff: Morag Orr helped with recruitment in Aberdeen; Christine King and Liz Steele, Bone Clinic, Freeman Hospital, Newcastle-upon-Tyne, helped with recruitment and follow-up in Newcastle; Sarah Cockayne, Research Assistant, Ruth Hildreth, Research Nurse, Cynthia Iglesias, Research Fellow, and Suezann Puffer, Research Assistant, York Trials Unit, York University, assisted the York-based staff.

Grant holders and steering group: Dr Mike Baverstock, GP Principal, supervised the Hertfordshire center; Marion Campbell, Reader, Health Services Research Unit, Aberdeen University, was a grant holder and provided statistical advice for the trial; Peter Campbell, Consultant, York District Hospital, was a grant holder and provided orthopedic input; Professor Cyrus Cooper was a grant holder and provided advice on study interpretation; Dr Roger Francis, Reader, Bone Clinic, Freeman Hospital, Newcastle-upon-Tyne, was a grant holder and supervised the Newcastle center and provided clinical expertise in osteoporosis; Dr Mike Kirby, GP, Hertfordshire Primary Care Network, was a grant holder and provided primary care expertise; Professor David Reid, Department of Medicine, Aberdeen University, was a grant holder and supervised the Aberdeen center and provided clinical expertise; Dr David J Torgerson, Director, York Trials Unit, York University, was principal investigator and undertook supervision of the York center as well as overall supervision of the project; Professor Ian Watt, York Trials Unit, York University, provided primary care advice and co-supervised the York center.