Hip fractures occur in 280,000 Americans (over 5,000 per week) and 36,000 Canadians (over 690 per week) annually. Hip fractures are associated with a 30% mortality rate at 1 year and profound temporary, and sometimes permanent, impairment of independence and quality of life. Worldwide, 4.5 million persons are disabled from hip fractures yearly with an expected increase to 21 million persons living with disability in the next 40 years. Hip fractures account for more hospital days than any other musculoskeletal injury and represent more than two thirds of all hospital days due to fractures. The disability adjusted life-years lost as a result of hip fractures ranks in the top 10 of all cause disability globally. Identifying the optimal approach to internal fixation is likely to improve the lives of tens of thousands of patients. Our primary objective is to assess the impact of sliding hip screws versus cannulated screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures. Our secondary objective is to determine the impact on health-related quality of like (Short Form-12, SF-12), functional outcomes (Western Ontario McMaster Osteoarthritis Index, WOMAC) and health utility (Euro-Qol-5D, EQ-5D). We propose a multi-center, concealed randomized trial design using minimization to determine patient allocation. Surgeons will use one of two surgical strategies in patients who have sustained a femoral neck fracture. The first strategy involves fixation of the fracture with multiple small diameter cancellous screws (i.e., cancellous screw group). The second treatment strategy involves fixation of the fracture with a single larger diameter screw with a side plate (i.e., sliding hip screw group). Study personnel will monitor critical aspects of peri-operative care and rehabilitation for protocol deviations. We will assess patients at hospital discharge, 2 weeks, 10 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery. The primary outcome is revision surgery within 2 years of the initial surgery. The secondary outcomes include patient quality of life (Short Form-12, SF-12), function (Western Ontario McMaster Osteoarthritis Index, WOMAC), and health utility (EuroQol-5D, EQ-5D). We will independently adjudicate revision surgery rates at regular intervals up to 2 years. This trial will not only change current orthopaedic practice, but will set a benchmark for the conduct of future orthopaedic trials.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
5R01AR055267-04
Application #
8142946
Study Section
Special Emphasis Panel (ZAR1-MLB-G (M1))
Program Officer
Panagis, James S
Project Start
2008-09-15
Project End
2014-02-28
Budget Start
2012-03-01
Budget End
2014-02-28
Support Year
4
Fiscal Year
2012
Total Cost
$263,102
Indirect Cost
$110,259
Name
University of Minnesota Twin Cities
Department
Orthopedics
Type
Schools of Medicine
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Zielinski, Stephanie M; Keijsers, Noël L; Praet, Stephan F E et al. (2014) Functional outcome after successful internal fixation versus salvage arthroplasty of patients with a femoral neck fracture. J Orthop Trauma 28:e273-80
Zielinski, S M; Bouwmans, C A M; Heetveld, M J et al. (2014) The societal costs of femoral neck fracture patients treated with internal fixation. Osteoporos Int 25:875-85
Zielinski, Stephanie M; Keijsers, Noel L; Praet, Stephan F E et al. (2013) Femoral neck shortening after internal fixation of a femoral neck fracture. Orthopedics 36:e849-58
Zielinski, Stephanie M; Viveiros, Helena; Heetveld, Martin J et al. (2012) Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience. Trials 13:5