Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

March 28, 2014 updated by: Northern Orthopaedic Division, Denmark

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Northern Jutland
      • Aalborg, Northern Jutland, Denmark
        • Northern Orthopaedic Division, Klinik Aalborg
      • Farsoe, Northern Jutland, Denmark
        • Northern Orthopaedic Division, Klinik Farsoe
      • Hjoerring, Northern Jutland, Denmark
        • Northern Orthopaedic Division, Klinik Hjoerring

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Principal Investigator: Martin Lamm, MD, Northern Orthopaedic Division

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

April 23, 2006

First Submitted That Met QC Criteria

April 23, 2006

First Posted (Estimate)

April 25, 2006

Study Record Updates

Last Update Posted (Estimate)

March 31, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON-04-005-LAM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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