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Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00464230
Enrollment
220
Registered
2007-04-23
Start date
2002-09-30
Completion date
2006-03-31
Last updated
2011-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fractures

Keywords

Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation, Hemiarthroplasty, Activities of Daily Living

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.

Interventions

PROCEDUREBipolar hemiarthroplasty (Charnley/Hastings)
PROCEDUREInternal fixation with two parallel screws (Olmed)

Sponsors

Ullevaal University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Harris Hip Score at 4, 12 and 24 months
Barthel ADL Index at 4, 12 and 24 months
Eq-5d (Euroqol) at 4, 12 and 24 months

Secondary

MeasureTime frame
Mortality
Morbidity
Re-operations
Complications

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026