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Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

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ClinicalTrials.gov Identifier: NCT00464230
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : July 1, 2011
Sponsor:
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Procedure: Bipolar hemiarthroplasty (Charnley/Hastings) Procedure: Internal fixation with two parallel screws (Olmed) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty
Study Start Date : September 2002
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Harris Hip Score at 4, 12 and 24 months
  2. Barthel ADL Index at 4, 12 and 24 months
  3. Eq-5d (Euroqol) at 4, 12 and 24 months

Secondary Outcome Measures :
  1. Mortality
  2. Re-operations
  3. Complications
  4. Morbidity


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464230


Locations
Norway
Orthopedic Center, Ulleval University Hospital
Oslo, Norway, 0408
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Chair: Jan Erik Madsen, MD, PhD Orthopedic Center, Ulleval University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00464230     History of Changes
Other Study ID Numbers: 12-2005-OS
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: April 2007

Keywords provided by Oslo University Hospital:
Displaced Femoral Neck Fractures
Treatment
Function
Pain
Quality of life
Complications
Reoperations
Internal Fixation
Hemiarthroplasty
Activities of Daily Living

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries