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Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

This study has been withdrawn prior to enrollment.
(recruitment was too slow, primary investigator has left the organisation)
Sponsor:
Information provided by:
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00317837
First received: April 23, 2006
Last updated: December 27, 2010
Last verified: December 2010
History of Changes

April 23, 2006
December 27, 2010
October 2004
December 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00317837 on ClinicalTrials.gov Archive Site
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Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture
Bipolar vs. Unipolar Hemiarthroplasty for Patients Aged 70 Years or Above, With a Dislocated Medial Femoral Neck Fracture

Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial femoral neck fracture. The study is prospective and randomised, and will be based on questionnaires, clinical examinations, registration of complications and radiographic evaluation at follow up at 3 months, 1 and 3 years postoperatively.
Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Femoral Neck Fractures
  • Procedure: Unipolar Hemiarthroplasty of the hip joint
    Unipolar Hemiarthroplasty of the hip joint
  • Procedure: bipolar hemiarthroplasty
    bipolar hemiarthroplasty
    Other Name: bipolar hemiarthroplasty
  • Active Comparator: 1
    Patients treated with a cemented modular hemiarthroplasty, with a unipolar head
    Intervention: Procedure: Unipolar Hemiarthroplasty of the hip joint
  • Active Comparator: 2
    Patients treated with a modular cemented hemiarthroplasty with a bipolar head.
    Intervention: Procedure: bipolar hemiarthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients ages 70 years or above
  • Dislocated medial femoral neck fracture (garden type 3-4)
  • Residence in the county of Northern Jutland, Denmark

Exclusion Criteria:

  • Pathologic fracture
  • Failed formerly internally fixed fracture of the affected hip
  • Degenerative joint disease of the affected hip or rheumatoid arthritis
  • Dementia
  • Terminal neoplastic disease
  • No informed consent
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00317837
ON-04-005-LAM
Not Provided
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Northern Orthopaedic Division, Denmark
Not Provided
Principal Investigator: Martin Lamm, MD Northern Orthopaedic Division
Northern Orthopaedic Division, Denmark
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP