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OpenTrials
Completed

NCT Number: NCT00764153

Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up

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, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.

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Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients were included from 2002-2004. Two years follow up was finished by 2006. Patients with displaced intracapsular femoral neck fractures were included and randomized by means of closed numbered envelopes to operation groups:

  • Two parallel screws (Olmed).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bipolar hemiarthroplasty

Procedure

Lateral approach. FWB.

Other names: Charnley/Hastings

Internal fixation

Procedure

Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)

Other names: Olmed (DePuy)

Primary outcomes

  1. Harris Hip Score

    Time frame: 5-6 years

Secondary outcomes

  1. Eq-5d

    Time frame: 5-6 years

  2. Barthel Index

    Time frame: 5-6 years

  3. Reoperations and complications

    Time frame: 5-6 years

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • Norwegian Foundation for Health and Rehabilitation
  • The Research Council of Norway

Registry information

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2008
Registry last updated
Oct 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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