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Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

Primary Purpose

Femoral Neck Fractures

Status

Withdrawn

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Unipolar Hemiarthroplasty of the hip joint

bipolar hemiarthroplasty

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Fracture of Femoral Neck

Eligibility Criteria

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

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

Sites / Locations

Northern Orthopaedic Division, Klinik Aalborg
Northern Orthopaedic Division, Klinik Farsoe
Northern Orthopaedic Division, Klinik Hjoerring

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Patients treated with a cemented modular hemiarthroplasty, with a unipolar head

Patients treated with a modular cemented hemiarthroplasty with a bipolar head.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00317837

First Posted

April 23, 2006

Last Updated

March 28, 2014

Sponsor

Northern Orthopaedic Division, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00317837

Brief Title

Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Recruitment was too slow, primary investigator has left the organisation

Study Start Date

October 2004 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northern Orthopaedic Division, Denmark

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Neck Fractures

Keywords

Fracture of Femoral Neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Patients treated with a cemented modular hemiarthroplasty, with a unipolar head

Arm Title

Arm Type

Active Comparator

Arm Description

Patients treated with a modular cemented hemiarthroplasty with a bipolar head.

Intervention Type

Procedure

Intervention Name(s)

Unipolar Hemiarthroplasty of the hip joint

Intervention Description

Unipolar Hemiarthroplasty of the hip joint

Intervention Type

Procedure

Intervention Name(s)

bipolar hemiarthroplasty

Intervention Description

bipolar hemiarthroplasty

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Lamm, MD

Organizational Affiliation

Northern Orthopaedic Division

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northern Orthopaedic Division, Klinik Aalborg

City

Aalborg

State/Province

Northern Jutland

Country

Denmark

Facility Name

Northern Orthopaedic Division, Klinik Farsoe

City

Farsoe

State/Province

Northern Jutland

Country

Denmark

Facility Name

Northern Orthopaedic Division, Klinik Hjoerring

City

Hjoerring

State/Province

Northern Jutland

Country

Denmark

12. IPD Sharing Statement

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Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

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