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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Sykehuset Asker og Baerum.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ullevaal University Hospital
Information provided by:
Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier:
NCT00746876
First received: September 3, 2008
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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 Intervention
Hip Fractures
Device: Unipolar hip hemiarthroplasty
Device: Bipolar hip hemiarthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sykehuset Asker og Baerum:

Primary Outcome Measures:
  • Acetabular wear measured with radiostereometry [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Harris hip score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Health-related quality of life (eq-5d) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Wender Figved, M.D., Ortopedisk avdeling, Sykehuset Asker og Bærum HF, Norway
ClinicalTrials.gov Identifier: NCT00746876     History of Changes
Other Study ID Numbers: HEMI-UNI-BIPOL
Study First Received: September 3, 2008
Last Updated: August 12, 2011
Health Authority: Norway: Norwegian Institute of Public Health
Norway: Directorate of Health

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

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

ClinicalTrials.gov processed this record on July 26, 2014