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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark Identifier:
First received: April 23, 2006
Last updated: March 28, 2014
Last verified: March 2014
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 Intervention
Femoral Neck Fractures
Procedure: Unipolar Hemiarthroplasty of the hip joint
Procedure: bipolar hemiarthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Northern Orthopaedic Division, Denmark:

Enrollment: 0
Study Start Date: October 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT00317837     History of Changes
Other Study ID Numbers: ON-04-005-LAM 
Study First Received: April 23, 2006
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Femoral Fractures
Hip Fractures
Hip Injuries
Leg Injuries
Wounds and Injuries processed this record on May 26, 2016