Undisplaced Femoral Neck Fractures in the Elderly: A Trial Comparing Internal Fixation to Hemiarthroplasty
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Undisplaced Femoral Neck Fractures in Patients Aged 70 Years and Older: A Multicentre Randomised Controlled Trial Comparing Internal Fixation to Hemiarthroplasty|
- Change in Harris Hip Score of 10 points or more. [ Time Frame: Baseline prior to fracture, 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]Harris hip score - a validated outcome measure to evaluate hip fracture intervention The physiotherapist recording the Harris Hips Score after 3 months, 1 year and two years is blinded. Clinical examination of the hip is carried out with masking of proximal thigh by proper clothes.
- Euro-Quol 5 dimension (Eq5d) [ Time Frame: Baseline prior to fracture, 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]Eq5D a validated measure of quality of life and to be utilised in health economic models comparing hospital and society costs of the two surgical methods compared. The investigator is blinded.
- Numeric pain intensity scale (0-10) [ Time Frame: Two weeks prior to fracture (retrospective), at discharge at an average 3-5 days after surgery, after 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]Visual analog scale variant with numbers from ranging from zero (no pain) to ten (worst possible pain). The investigator is blinded.
- Timed Up and Go test (TUG test) [ Time Frame: 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]Patient sits on a chair, rises, walks 3 meters passing a mark, turns around, walks back and sits down. The time is recorded in seconds. The investigator is blinded.
- Reoperation rate [ Time Frame: 5 years after surgery ] [ Designated as safety issue: No ]All complications are continually recorded in both trial arms.
- Death [ Time Frame: 5 years after surgery ] [ Designated as safety issue: No ]All deaths are recorded
- Mini mental state(MMSE-NR) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Mini mental state is recorded only at 3 months follow-up
- Hospital and society costs [ Time Frame: at baseline prior to fracture, at discharge, 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]Use of governmental and private health care services and assistance by family members and relatives are all recorded. Validated health economical models are used to calculate the costs.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Internal fixation - standard treatment
Internal fixation with two parallel cancellous screws (Hip Pins(R)) Current standard treatment
Device: internal fixation
Two cancellous parallel screws - internal fixation of the femoral neck fracture
Experimental: Hemi - arthroplasty
cemented Hemi - arthroplasty (Exeter(R)) modular system V40 by Stryker. Refobacin cement.
Device: Hemi - arthroplasty
cemented hemi - arthroplasty
The consequences of a femoral neck fracture still have a substantial impact on the individual patient´s health as well as on society. Approximately 5000 individuals suffer a fracture of the femoral neck annually in Norway. The mortality rate approximates 25% during the first year after this injury. The hospital costs of treating a single femoral neck fracture, have been estimated to 20 000 euros.
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.
Several studies with a high level of evidence have elucidated management of displaced femoral neck fractures. There is increasing evidence favouring joint replacement surgery over internal fixation when treating displaced femoral neck fractures. However, management of undisplaced and minimally displaced femoral neck fractures has received less attention.
According to the Cochrane Library, there are no randomised controlled trials comparing internal fixation to hemiarthroplasty in patients with undisplaced femoral neck fractures. Previous studies have focused mostly on fracture healing, equating fracture union and success. However, recent studies report decreased functional and life quality scores amongst patients with undisplaced femoral neck fractures treated with internal fixation. The control group in these studies consists of patients with a displaced femoral neck fracture treated with hemi - arthroplasty. 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. Then again, this is associated with lower functional and life quality scores. 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. 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.
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. The two methods that will be compared are internal fixation with two screws and modern modular hemiarthroplasty. 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 primary follow-up length is set to two years, but a long-term follow-up five years after surgery is also planned. It is important to include the cognitively impaired patients as they account for 20-25% of the study population. Patients who cannot provide informed consent due to impaired cognitive function, are included if consent is provided by a family member or relative.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770769
|Akershus University Hospital|
|Lørenskog, Norway, N-1478|
|Study Chair:||Torbjørn Omland, Professor||University Hospital, Akershus|