Overview

This trial is active, not recruiting.

Condition femoral neck fractures
Treatments hemi - arthroplasty, internal fixation
Sponsor University Hospital, Akershus
Collaborator University of Oslo
Start date February 2012
End date February 2017
Trial size 220 participants
Trial identifier NCT01770769, NEM-2011/2296

Summary

Clinical 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. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These fractures have been associated with a good prognosis and likewise a good functional outcome. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Internal fixation with two parallel cancellous screws (Hip Pins(R)) Current standard treatment
internal fixation Hip Pins (R)
Two cancellous parallel screws - internal fixation of the femoral neck fracture
(Experimental)
cemented Hemi - arthroplasty (Exeter(R)) modular system V40 by Stryker. Refobacin cement.
hemi - arthroplasty Hemi - arthroplasty by Stryker - Exeter V40(R)
cemented hemi - arthroplasty

Primary Outcomes

Measure
Change in Harris Hip Score of 10 points or more.
time frame: Baseline prior to fracture, 3 months, 1 year and 2 years

Secondary Outcomes

Measure
Euro-Quol 5 dimension (Eq5d)
time frame: Baseline prior to fracture, 3 months, 1 year and 2 years
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
Timed Up and Go test (TUG test)
time frame: 3 months, 1 year and 2 years
Reoperation rate
time frame: 5 years after surgery
Death
time frame: 5 years after surgery
Mini mental state(MMSE-NR)
time frame: 3 months
Hospital and society costs
time frame: at baseline prior to fracture, at discharge, 3 months, 1 year and 2 years

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: - Age 70 years or older - Undisplaced or minimally displaced intracapsular femoral neck fracture (Garden I/II) - Patient able to walk before injury (all aids allowed) - Patient lives within the catchment area of the three involved centres Exclusion Criteria: - Displaced fractures (Garden III/IV) and impacted fractures with minimal varus - Pathologic fracture - Current soft tissue or deep infection in the hip or pelvis area - ASA IV patients as classified by the anesthesiologist on call - Other contraindications to either of the two methods compared - Temporarily impaired cognitive function: (That is when the patient is judged as unable to provide an informed consent by the surgeon on call and there is no previous history of impaired cognitive function as documented by previous hospital record or a family member / proxy)

Additional Information

Official title Undisplaced Femoral Neck Fractures in Patients Aged 70 Years and Older: A Multicentre Randomised Controlled Trial Comparing Internal Fixation to Hemiarthroplasty
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Akershus.