Clinical trial NCT00464230: Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures
Official title: The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoral Neck Fractures
Keywords: Displaced Femoral Neck Fractures
Treatment
Function
Pain
Quality of life
Complications
Reoperations
Internal Fixation
Hemiarthroplasty
Activities of Daily Living
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2007-04-23
Enrollment: 220
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, but there is no consensus about which procedure that gives best functional results.

Detailed description: We plan to include patients with displaced intracapsular femoral neck fractures. The patients will be randomized by means of closed numbered envelopes to operation groups:

1. Two parallel screws (Olmed).
2. Hemiarthroplasty with Charnley/ Hastings prosthesis. A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.

Eligibility criteria: Inclusion Criteria:

* Displaced femoral neck fracture
* Age 60 or above
* Able to walk (any aids allowed)

Exclusion Criteria:

* Anesthesiologically unfit for arthroplasty surgery
* Previous symptomatic hip pathology (i.e. arthritis)
* Pathological fracture
* Delay of more than 96 hours from injury to treatment
* Not living in hospital area

Primary outcomes:
measure: Harris Hip Score at 4, 12 and 24 months
measure: Barthel ADL Index at 4, 12 and 24 months
measure: Eq-5d (Euroqol) at 4, 12 and 24 months
Secondary outcomes:
measure: Mortality
measure: Re-operations
measure: Complications
measure: Morbidity
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Orthopedic Center, Ulleval University Hospital
Study officials:
affiliation: Orthopedic Center, Ulleval University Hospital
name: Jan Erik Madsen, MD, PhD
role: STUDY_CHAIR
References:
citation: Waaler Bjornelv GM, Frihagen F, Madsen JE, Nordsletten L, Aas E. Hemiarthroplasty compared to internal fixation with percutaneous cannulated screws as treatment of displaced femoral neck fractures in the elderly: cost-utility analysis performed alongside a randomized, controlled trial. Osteoporos Int. 2012 Jun;23(6):1711-9. doi: 10.1007/s00198-011-1772-1. Epub 2011 Oct 14.
citation: Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.