Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

Femoral Neck Fractures Clinical Trial

Official title:

Bipolar vs. Unipolar Hemiarthroplasty for Patients Aged 70 Years or Above, With a Dislocated Medial Femoral Neck Fracture

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00317837
• Other study ID #: ON-04-005-LAM
• Status: Withdrawn
• Phase: N/A
• First received: April 23, 2006
• Last updated: March 28, 2014
• Start date: October 2004
• Est. completion date: December 2010

Study information

• Verified date: March 2014
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Unipolar Hemiarthroplasty of the hip joint
Unipolar Hemiarthroplasty of the hip joint
• bipolar hemiarthroplasty
bipolar hemiarthroplasty

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Klinik Aalborg	Aalborg	Northern Jutland
Denmark	Northern Orthopaedic Division, Klinik Farsoe	Farsoe	Northern Jutland
Denmark	Northern Orthopaedic Division, Klinik Hjoerring	Hjoerring	Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark,