Evaluation of Surgical Fixation Using Alternative Implants for the Treatment of Hip Fractures
The primary purpose of this study is to assess the impact of sliding hip screws versus cannulated screw fixation on rates of revision surgery at 2 years in individuals over 50 years of age with femoral neck fractures. The secondary objective of the study is to determine the impact of sliding hip screws versus cannulated screw fixation on health-related quality of life, functional outcomes and generic utility measures.
Hip fractures occur in 280,000 Americans (over 5,000 per week) and 36,000 (over 690 per week) Canadians annually. The number of hip fractures is likely to exceed 500,000 annually in the United States and 88,000 in Canada. The estimated annual health care costs will reach a staggering $9.8 billion in the United States and $650 million in Canada. Hip fractures are associated with a 30% mortality rate 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. Experimental data suggest that cancellous screws offer greater preservation of blood supply, while sliding hip screws provide greater biomechanical stability to bending stresses. While both arguments are persuasive, the impacts of these biologic alterations on outcomes that are important to patients offer more compelling guidance for clinical practice.
Although current opinion among orthopaedic surgeons favour the use of cancellous screws over sliding hip screws, there remains sufficient divergence in perceptions and sufficient interest to resolve this issue to warrant a large randomized controlled trial. Despite the popularity of cancellous screw fixation, there is a strong biologic rationale supporting the sliding hip screws, a more biomechanically stable construct, in older patients with osteopenia or osteoporosis. While our meta-analysis provides indirect and direct evidence that a sliding hip screw may reduce revision surgery rates, the evidence remains far from definitive. The current best estimate of treatment effect with sliding hip screws is based upon small trials with methodological limitations including unconcealed randomization and lack of blinding. The resulting estimates include wide confidence intervals (i.e., displaced fractures: RRR=27%, 95%CI: 48%, -4%, P=0.08). Whatever approach to internal fixation proves best, a large proportion of patients will continue to need revision surgery that is associated with high morbidity and appreciable mortality
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Multiple Cancellous Screws Fixation with (Gouffon, Uppsala, von Bahr, Hansson hook pins), Sliding Hip Screw with (Stryker, DePuy, Synthes, Smith and Nephew, Zimmer)
Erasmus Medical Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00557167
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Implantable fracture fixation devices attached to bone fragments with screws to bridge the fracture gap and shield the fracture site from stress as bone heals. (UMDNS, 1999)
Surgical Fixation Devices
Devices used to hold tissue structures together for repair, reconstruction or to close wounds. They may consist of adsorbable or non-adsorbable, natural or synthetic materials. They include tissue adhesives, skin tape, sutures, buttons, staples, clips, screws, etc., each designed to conform to various tissue geometries.
Crumbling or smashing of cancellous BONE by forces acting parallel to the long axis of bone. It is applied particularly to vertebral body fractures (SPINAL FRACTURES). (Blauvelt and Nelson, A Manual of Orthopedic Terminology, 1994, p4)
Multiple Birth Offspring
The offspring in multiple pregnancies (PREGNANCY, MULTIPLE): TWINS; TRIPLETS; QUADRUPLETS; QUINTUPLETS; etc.
Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with thi...
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