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Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

U

Ullevaal University Hospital

Status and phase

Completed
Phase 4

Conditions

Femoral Neck Fractures

Treatments

Procedure: Bipolar hemiarthroplasty (Charnley/Hastings)
Procedure: Internal fixation with two parallel screws (Olmed)

Study type

Interventional

Funder types

Other

Identifiers

NCT00464230
12-2005-OS

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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