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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This study has been withdrawn prior to enrollment.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
  Purpose

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:

U.S. FDA Resources

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

Estimated Enrollment: 100
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
Other Name: bipolar hemiarthroplasty

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317837

Locations
Denmark
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
Investigators
Principal Investigator: Martin Lamm, MD Northern Orthopaedic Division
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00317837     History of Changes
Other Study ID Numbers: ON-04-005-LAM
Study First Received: April 23, 2006
Last Updated: December 27, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on June 18, 2013