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WithdrawnNCT00317837Updated Mar 31, 2014

Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

An interventional study of Unipolar Hemiarthroplasty of the hip joint and bipolar hemiarthroplasty in Femoral Neck Fractures, sponsored by Northern Orthopaedic Division, Denmark. Withdrawn at 3 sites in Denmark. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2014-03-31.

Sponsored by Northern Orthopaedic Division, Denmark · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Recruitment was too slow, primary investigator has left the organisation
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Femoral Neck Fractures

Keywords

  • Fracture of Femoral Neck
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

Browse Fractures, Bone studies →

Lead sponsor

Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    1

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

    Procedure: Unipolar Hemiarthroplasty of the hip joint

  • Active comparator
    2

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

    Procedure: bipolar hemiarthroplasty

Interventions

  • ProcedureUnipolar Hemiarthroplasty of the hip joint

    Unipolar Hemiarthroplasty of the hip joint

  • Procedurebipolar hemiarthroplasty

    bipolar hemiarthroplasty

06

Study locations

3 sites
  • 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, Denmark
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00317837
Lead sponsor
Northern Orthopaedic Division, Denmark
Responsible party
Sponsor
First posted
Apr 25, 2006
Start date
Oct 2004
Primary completion
Dec 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Mar 31, 2014

Study contacts

Martin Lamm, MD
principal investigator · Northern Orthopaedic Division
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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