Evaluation of Surgical Fixation Using Alternative Implants for the Treatment of Hip Fractures
Summary
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.
Description
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
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Hip Fractures
Intervention
Multiple Cancellous Screws Fixation with (Gouffon, Uppsala, von Bahr, Hansson hook pins), Sliding Hip Screw with (Stryker, DePuy, Synthes, Smith and Nephew, Zimmer)
Location
Erasmus Medical Center
Rotterdam
Netherlands
3000 CA
Status
Recruiting
Source
McMaster University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00557167
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bone Plates
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.
Fractures, Compression
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.
Clinical Trials
Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)
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...
The purpose of this study is to compare between two methods of internal fixation, the 3-4 parallel screws or the Targon FN implant in gardens type 1-2 or Pauwels type 1-2 femoral neck frac...
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system provides...
A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
The role of operative fixation of unstable, displaced lateral malleolus fractures is well-established (Mayer, Mak, and Yablon). However, the optimal type of fixation remains the subject of...
Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures
An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any...
PubMed Articles
The biomechanics of screws, cerclage wire and cerclage cable.
In contrast to fracture fixation, when performing an osteotomy the surgeon is able to plan preoperatively. The resulting fixation and compression of the bone fragments are the most important points. A...
In lower cancellous apparent bone density, it can be difficult to achieve adequate screw fixation and hence stable fracture fixation. Different strategies have been proposed, one of them is through au...
An obvious means to improve the fixation of a cancellous bone screw is to augment the surrounding bone with cement. Previous studies have shown that bone augmentation with Calcium Phosphate (CaP) ceme...
BACKGROUND: Neck of femur fractures (NOFFs) are a common cause of morbidity and mortality in our community. Minimally displaced intracapsular fractures are treated with internal fixation by a two-hole...
Does An Enhanced Surface Finish Improve Acetabular Fixation in Revision Total Hip Arthroplasty?
High-porosity "cancellous metal" coatings have been introduced to increase the fixation and biologic incorporation of acetabular cups. The strength of initial fixation provided by a cancellous metal c...
