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Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

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.
ClinicalTrials.gov Identifier: NCT00317837
Recruitment Status : Withdrawn (Recruitment was too slow, primary investigator has left the organisation)
First Posted : April 25, 2006
Last Update Posted : March 31, 2014
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment
Femoral Neck Fractures Procedure: Unipolar Hemiarthroplasty of the hip joint Procedure: bipolar hemiarthroplasty

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bipolar vs. Unipolar Hemiarthroplasty for Patients Aged 70 Years or Above, With a Dislocated Medial Femoral Neck Fracture
Study Start Date : October 2004
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Patients treated with a cemented modular hemiarthroplasty, with a unipolar head
Procedure: Unipolar Hemiarthroplasty of the hip joint
Unipolar Hemiarthroplasty of the hip joint
Active Comparator: 2
Patients treated with a modular cemented hemiarthroplasty with a bipolar head.
Procedure: bipolar hemiarthroplasty
bipolar hemiarthroplasty

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00317837

Northern Orthopaedic Division, Klinik Aalborg
Aalborg, Northern Jutland, Denmark
Northern Orthopaedic Division, Klinik Farsoe
Farsoe, Northern Jutland, Denmark
Northern Orthopaedic Division, Klinik Hjoerring
Hjoerring, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Principal Investigator: Martin Lamm, MD Northern Orthopaedic Division

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00317837     History of Changes
Other Study ID Numbers: ON-04-005-LAM
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by Northern Orthopaedic Division, Denmark:
Fracture of Femoral Neck

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries