Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

This study is currently recruiting participants.

Verified by Northern Orthopaedic Division, Denmark, August 2008

Sponsored by:	Northern Orthopaedic Division, Denmark
Information provided by:	Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:	NCT00317837

Purpose

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.

Condition	Intervention
Femoral Neck Fractures	Procedure: Unipolar Hemiarthroplasty of the hip joint Procedure: bipolar hemiarthroplasty

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Bipolar vs. Unipolar Hemiarthroplasty for Patients Aged 70 Years or Above, With a Dislocated Medial Femoral Neck Fracture

Further study details as provided by Northern Orthopaedic Division, Denmark:

Estimated Enrollment:	100
Study Start Date:	October 2004
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients treated with a cemented modular hemiarthroplasty, with a unipolar head	Procedure: Unipolar Hemiarthroplasty of the hip joint Unipolar Hemiarthroplasty of the hip joint
2: Active Comparator Patients treated with a modular cemented hemiarthroplasty with a bipolar head.	Procedure: bipolar hemiarthroplasty bipolar hemiarthroplasty

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317837

Contacts

Contact: Mogens Laursen, MD

mogens.berg.laursen@rn.dk

Locations

Denmark, Northern Jutland
Northern Orthopaedic Division, Klinik Aalborg	Recruiting
Aalborg, Northern Jutland, Denmark
Contact: Martin Lamm, MD martin.lamm@rn.dk
Principal Investigator: Martin Lamm, MD
Northern Orthopaedic Division, Klinik Hjoerring	Recruiting
Hjoerring, Northern Jutland, Denmark
Contact: Martin Lamm, MD martin.lamm@rn.dk
Principal Investigator: Martin Lamm, MD
Northern Orthopaedic Division, Klinik Farsoe	Not yet recruiting
Farsoe, Northern Jutland, Denmark
Contact: Martin Lamm, MD on.mal@nja.dk
Principal Investigator: Martin Lamm, MD

Sponsors and Collaborators

Northern Orthopaedic Division, Denmark

Investigators

Principal Investigator:

Martin Lamm, MD

Northern Orthopaedic Division

More Information

Study ID Numbers:	ON-04-005-LAM
Study First Received:	April 23, 2006
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00317837
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Northern Orthopaedic Division, Denmark:

Fracture of Femoral Neck

Study placed in the following topic categories:

Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on January 16, 2009