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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764153
First Posted: October 1, 2008
Last Update Posted: October 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Norwegian Foundation for Health and Rehabilitation
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital ( Ullevaal University Hospital )
  Purpose
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.

Condition Intervention
Femoral Neck Fractures Procedure: Bipolar hemiarthroplasty Procedure: Internal fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital ( Ullevaal University Hospital ):

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: 5-6 years ]

Secondary Outcome Measures:
  • Eq-5d [ Time Frame: 5-6 years ]
  • Barthel Index [ Time Frame: 5-6 years ]
  • Reoperations and complications [ Time Frame: 5-6 years ]

Enrollment: 222
Study Start Date: October 2002
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Internal fixation
Closed reduction and internal fixation with two parallel screws (Olmed)
Procedure: Internal fixation
Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)
Other Name: Olmed (DePuy)
Bipolar hemiarthroplasty
Hemiarthroplasty with Charnley/ Hastings prosthesis
Procedure: Bipolar hemiarthroplasty
Lateral approach. FWB.
Other Name: Charnley/Hastings

Detailed Description:

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:

  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

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
  Contacts and Locations
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): NCT00764153


Sponsors and Collaborators
Ullevaal University Hospital
Norwegian Foundation for Health and Rehabilitation
The Research Council of Norway
Investigators
Study Chair: Jan Erik Madsen, MD PhD Orthopedic Center, Ulleval University Hospital, Oslo, Norway
  More Information

Publications:
Responsible Party: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00764153     History of Changes
Other Study ID Numbers: 12-2005-OS-2
First Submitted: September 29, 2008
First Posted: October 1, 2008
Last Update Posted: October 23, 2014
Last Verified: October 2014

Keywords provided by Oslo University Hospital ( Ullevaal 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