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

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ClinicalTrials.gov Identifier: NCT00764153
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : October 23, 2014
Sponsor:
Collaborators:
Norwegian Foundation for Health and Rehabilitation
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital ( Ullevaal 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, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Procedure: Bipolar hemiarthroplasty Procedure: Internal fixation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
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
Study Start Date : October 2002
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  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 ]


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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): 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

Publications:
Responsible Party: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00764153     History of Changes
Other Study ID Numbers: 12-2005-OS-2
First Posted: October 1, 2008    Key Record Dates
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