Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. (HEMIUNIBIPOL)

April 18, 2016 updated by: Wender Figved, Sykehuset Asker og Baerum

Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.

Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.

Study Type

Interventional

Enrollment (Actual)

28

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

  • Norway
    • Rud
      • Baerum, Rud, Norway, 1309
        • Asker and Baerum Hospital

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

68 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Displaced femoral neck fracture
  • 70 years or older
  • Ambulatory status: No walking aids
  • No mental illness or impaired cognitive function

Exclusion Criteria:

  • Pathological fracture (malignant disease)
  • Ongoing systemic or local infection
  • Radiologically presence of acetabular wear (osteoarthrosis)

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: Unipolar
15 patients randomized for treatment with a unipolar hip hemiarthroplasty
Device: Unipolar hip hemiarthroplasty
Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Other Names:
  • Modular Cathcart Unipolar, DePuy/Johnson and Johnson
Active Comparator: Bipolar
15 patients randomized for treatment with a bipolar hip hemiarthroplasty
Device: Bipolar hip hemiarthroplasty
Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Other Names:
  • Celf-Centering Bipolar, DePuy/Johnson and Johnson

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acetabular wear measured with radiostereometry
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Harris hip score
Time Frame: 24 months
24 months
Health-related quality of life (eq-5d)
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

Sykehuset Asker og Baerum

Collaborators

Ullevaal University Hospital

Investigators

  • Study Director: Asbjørn Hjall, M.D., Asker and Baerum Hospital, Norway

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

September 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMI-UNI-BIPOL

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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