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

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ClinicalTrials.gov Identifier: NCT00746876
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
Ullevaal University Hospital
Information provided by (Responsible Party):
Wender Figved, Sykehuset Asker og Baerum

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Device: Unipolar hip hemiarthroplasty Device: Bipolar hip hemiarthroplasty Not Applicable

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.
Study Start Date : September 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2015

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U.S. FDA Resources

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 Name: 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 Name: Celf-Centering Bipolar, DePuy/Johnson and Johnson



Primary Outcome Measures :
  1. Acetabular wear measured with radiostereometry [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Harris hip score [ Time Frame: 24 months ]
  2. Health-related quality of life (eq-5d) [ Time Frame: 24 months ]


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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746876


Locations
Norway
Asker and Baerum Hospital
Baerum, Rud, Norway, 1309
Sponsors and Collaborators
Sykehuset Asker og Baerum
Ullevaal University Hospital
Investigators
Study Director: Asbjørn Hjall, M.D. Asker and Baerum hospital, Norway

Responsible Party: Wender Figved, MD PhD, Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier: NCT00746876     History of Changes
Other Study ID Numbers: HEMI-UNI-BIPOL
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Wender Figved, Sykehuset Asker og Baerum:
Hip
Fracture
Femoral neck
Hemiarthroplasty
Bipolar
Unipolar
Displaced femoral neck fractures

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