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Undisplaced Femoral Neck Fractures in the Elderly: A Trial Comparing Internal Fixation to Hemiarthroplasty

NCT01770769 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-11-06

No results posted yet for this study

Summary

Clinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These fractures have been associated with a good prognosis and likewise a good functional outcome. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. Hence the investigators call for a randomised controlled trial comparing pain, function, walking ability, quality of life, re-operation rates and complications after internal fixation versus hemiarthroplasty in patients aged 70 years and older.

Conditions

  • Femoral Neck Fractures

Interventions

DEVICE

Hemi - arthroplasty

modular hemiarthroplasty

DEVICE

internal fixation

Two cancellous parallel screws - internal fixation of the femoral neck fracture

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Asker & Baerum Hospital

    collaborator OTHER

  • Sykehuset Innlandet HF

    collaborator OTHER

  • Vestre Viken Hospital Trust

    collaborator OTHER

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Torbjørn Omland, Professor · University Hospital, Akershus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-06
Primary Completion
2020-02-06
Completion
2020-02-06

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01770769 on ClinicalTrials.gov