Bipolar Versus Unipolar Hemiarthroplasty for Patients Wit... | NCT00317837

Studies
Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

NCT00317837

Sponsor

Northern Orthopaedic Division, Denmark

Status

Withdrawn

Last Update Posted

Mar 31, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Femoral Neck Fractures

Interventions

Unipolar Hemiarthroplasty of the hip joint
bipolar hemiarthroplasty

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment was too slow, primary investigator has left the organisation

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Apr 23, 2006

First Submission Date that Met QC Criteria

Apr 23, 2006

First Posted Date

Apr 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2014

Last Update Posted Date

Mar 31, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Patients treated with a cemented modular hemiarthroplasty, with a unipolar head	Procedure: Unipolar Hemiarthroplasty of the hip joint
2	Active Comparator	Patients treated with a modular cemented hemiarthroplasty with a bipolar head.	Procedure: bipolar hemiarthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unipolar Hemiarthroplasty of the hip joint	Procedure	Unipolar Hemiarthroplasty of the hip joint	1

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Lamm, MD	Northern Orthopaedic Division	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern Orthopaedic Division, Klinik Aalborg		Aalborg	Northern Jutland		Denmark
Northern Orthopaedic Division, Klinik Farsoe

Condition Browse Module

MeSH Terms

ID	Term
D005265	Femoral Neck Fractures

Ancestor Terms

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided