NCT00317837

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

6.2 years

First QC Date

April 23, 2006

Last Update Submit

March 28, 2014

Conditions

Femoral Neck Fractures

Keywords

Fracture of Femoral Neck

Study Arms (2)

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

Unipolar Hemiarthroplasty of the hip jointPROCEDURE

Unipolar Hemiarthroplasty of the hip joint

1
bipolar hemiarthroplastyPROCEDURE

bipolar hemiarthroplasty

2

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients ages 70 years or above
  • Dislocated medial femoral neck fracture (garden type 3-4)
  • Residence in the county of Northern Jutland, Denmark

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northern Orthopaedic Division, Klinik Aalborg

Aalborg, Northern Jutland, Denmark

Location

Northern Orthopaedic Division, Klinik Farsoe

Farsø, Northern Jutland, Denmark

Location

Northern Orthopaedic Division, Klinik Hjoerring

Hjørring, Northern Jutland, Denmark

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Martin Lamm, MD

    Northern Orthopaedic Division

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2006

First Posted

April 25, 2006

Study Start

October 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

DK(3)