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

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Unipolar hip hemiarthroplasty
Bipolar hip hemiarthroplasty
Sponsored by
Sykehuset Asker og Baerum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Hip, Fracture, Femoral neck, Hemiarthroplasty, Bipolar, Unipolar, Displaced femoral neck fractures

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Asker and Baerum Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Unipolar

Bipolar

Arm Description

15 patients randomized for treatment with a unipolar hip hemiarthroplasty

15 patients randomized for treatment with a bipolar hip hemiarthroplasty

Outcomes

Primary Outcome Measures

Acetabular wear measured with radiostereometry

Secondary Outcome Measures

Harris hip score
Health-related quality of life (eq-5d)

Full Information

First Posted
September 3, 2008
Last Updated
April 18, 2016
Sponsor
Sykehuset Asker og Baerum
Collaborators
Ullevaal University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00746876
Brief Title
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.
Acronym
HEMIUNIBIPOL
Official Title
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset Asker og Baerum
Collaborators
Ullevaal University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip, Fracture, Femoral neck, Hemiarthroplasty, Bipolar, Unipolar, Displaced femoral neck fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unipolar
Arm Type
Active Comparator
Arm Description
15 patients randomized for treatment with a unipolar hip hemiarthroplasty
Arm Title
Bipolar
Arm Type
Active Comparator
Arm Description
15 patients randomized for treatment with a bipolar hip hemiarthroplasty
Intervention Type
Device
Intervention Name(s)
Unipolar hip hemiarthroplasty
Other Intervention Name(s)
Modular Cathcart Unipolar, DePuy/Johnson and Johnson
Intervention Description
Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Intervention Type
Device
Intervention Name(s)
Bipolar hip hemiarthroplasty
Other Intervention Name(s)
Celf-Centering Bipolar, DePuy/Johnson and Johnson
Intervention Description
Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Primary Outcome Measure Information:
Title
Acetabular wear measured with radiostereometry
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Harris hip score
Time Frame
24 months
Title
Health-related quality of life (eq-5d)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asbjørn Hjall, M.D.
Organizational Affiliation
Asker and Baerum hospital, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Asker and Baerum Hospital
City
Baerum
State/Province
Rud
ZIP/Postal Code
1309
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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