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

Primary Purpose

Femoral Neck Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bipolar hemiarthroplasty
Internal fixation
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation, Hemiarthroplasty, Activities of Daily Living

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Internal fixation

    Bipolar hemiarthroplasty

    Arm Description

    Closed reduction and internal fixation with two parallel screws (Olmed)

    Hemiarthroplasty with Charnley/ Hastings prosthesis

    Outcomes

    Primary Outcome Measures

    Harris Hip Score

    Secondary Outcome Measures

    Eq-5d
    Barthel Index
    Reoperations and complications

    Full Information

    First Posted
    September 29, 2008
    Last Updated
    October 22, 2014
    Sponsor
    Ullevaal University Hospital
    Collaborators
    Norwegian Foundation for Health and Rehabilitation, The Research Council of Norway
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00764153
    Brief Title
    Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up
    Official Title
    Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ullevaal University Hospital
    Collaborators
    Norwegian Foundation for Health and Rehabilitation, The Research Council of Norway

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femoral Neck Fractures
    Keywords
    Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation, Hemiarthroplasty, Activities of Daily Living

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    222 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Internal fixation
    Arm Type
    Other
    Arm Description
    Closed reduction and internal fixation with two parallel screws (Olmed)
    Arm Title
    Bipolar hemiarthroplasty
    Arm Type
    Other
    Arm Description
    Hemiarthroplasty with Charnley/ Hastings prosthesis
    Intervention Type
    Procedure
    Intervention Name(s)
    Bipolar hemiarthroplasty
    Other Intervention Name(s)
    Charnley/Hastings
    Intervention Description
    Lateral approach. FWB.
    Intervention Type
    Procedure
    Intervention Name(s)
    Internal fixation
    Other Intervention Name(s)
    Olmed (DePuy)
    Intervention Description
    Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)
    Primary Outcome Measure Information:
    Title
    Harris Hip Score
    Time Frame
    5-6 years
    Secondary Outcome Measure Information:
    Title
    Eq-5d
    Time Frame
    5-6 years
    Title
    Barthel Index
    Time Frame
    5-6 years
    Title
    Reoperations and complications
    Time Frame
    5-6 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Erik Madsen, MD PhD
    Organizational Affiliation
    Orthopedic Center, Ulleval University Hospital, Oslo, Norway
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18056740
    Citation
    Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.
    Results Reference
    background
    PubMed Identifier
    18656868
    Citation
    Frihagen F, Grotle M, Madsen JE, Wyller TB, Mowinckel P, Nordsletten L. Outcome after femoral neck fractures: a comparison of Harris Hip Score, Eq-5d and Barthel Index. Injury. 2008 Oct;39(10):1147-56. doi: 10.1016/j.injury.2008.03.027. Epub 2008 Jul 25.
    Results Reference
    background
    PubMed Identifier
    23975250
    Citation
    Stoen RO, Lofthus CM, Nordsletten L, Madsen JE, Frihagen F. Randomized trial of hemiarthroplasty versus internal fixation for femoral neck fractures: no differences at 6 years. Clin Orthop Relat Res. 2014 Jan;472(1):360-7. doi: 10.1007/s11999-013-3245-7. Epub 2013 Aug 24.
    Results Reference
    background

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

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