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This study has been withdrawn prior to enrollment.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 (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00317837
First received: April 23, 2006
Last updated: March 28, 2014
Last verified: March 2014

April 23, 2006
March 28, 2014
October 2004
December 2010   (final data collection date for primary outcome measure)
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Not Provided
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
Not Provided
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Withdrawn
0
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
Northern Orthopaedic Division, Denmark
Northern Orthopaedic Division, Denmark
Not Provided
Principal Investigator: Martin Lamm, MD Northern Orthopaedic Division
Northern Orthopaedic Division, Denmark
March 2014

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