It is important to include the cognitively impaired patients as they account for 20-25% of the study population. The primary follow-up length is set to two years, but a long-term follow-up five years after surgery is also planned. The primary outcome measure is a difference of at least 10 points in Harris Hip Score (95% power, standard deviation approximates 15 points from previous Norwegian patient series). The two methods that will be compared are internal fixation with two screws and modern modular hemiarthroplasty. Thus, our research group will conduct a prospective randomised controlled trial to identify any differences in clinical outcome after surgical treatment of undisplaced femoral neck fractures in patients aged 70 years and older. Gjertsen et al analysed data for the Norwegian hip fracture registry from more than 4000 patients to demonstrate that treatment with hemiarthroplasty, due to a displaced femoral neck fracture, is associated with better function and less pain than treatment with internal fixation due to an undisplaced femoral neck fracture. In Rogmark´s series of patients with undisplaced femoral neck fractures treated with internal fixation, 25% patients report daily pain from the affected hip upon walking, one and a half year after surgery. Then again, this is associated with lower functional and life quality scores. Zlowodzki et al showed, by means of validated assessment scores, that patients with internally fixated undisplaced femoral neck fractures often experience shortening of the injured limb. The control group in these studies consists of patients with a displaced femoral neck fracture treated with hemi - arthroplasty. However, recent studies report decreased functional and life quality scores amongst patients with undisplaced femoral neck fractures treated with internal fixation. Previous studies have focused mostly on fracture healing, equating fracture union and success. However, management of undisplaced and minimally displaced femoral neck fractures has received less attention.Īccording to the Cochrane Library, there are no randomised controlled trials comparing internal fixation to hemiarthroplasty in patients with undisplaced femoral neck fractures. There is increasing evidence favouring joint replacement surgery over internal fixation when treating displaced femoral neck fractures. Several studies with a high level of evidence have elucidated management of displaced femoral neck fractures. In spite of relatively well-documented treatment protocols, there is still a need for prospective randomised controlled trials to determine the optimal treatment of certain sub-groups of patients presenting with a femoral neck fracture. The hospital costs of treating a single femoral neck fracture, have been estimated to 20 000 euros. The mortality rate approximates 25% during the first year after this injury. Approximately 5000 individuals suffer a fracture of the femoral neck annually in Norway. The consequences of a femoral neck fracture still have a substantial impact on the individual patient´s health as well as on society. Condition or diseaseĭevice: Hemi - arthroplasty Device: internal fixation Hence the investigators call for a randomised controlled trial comparing pain, function, walking ability, quality of life, re-operation rates and complications after internal fixation versus hemiarthroplasty in patients aged 70 years and older. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. These fractures have been associated with a good prognosis and likewise a good functional outcome. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. Why Should I Register and Submit Results?Ĭlinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws.
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