Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up

October 22, 2014 updated by: Ullevaal University Hospital
An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were included from 2002-2004. Two years follow up was finished by 2006. Patients with displaced intracapsular femoral neck fractures were included and randomized by means of closed numbered envelopes to operation groups:

  1. Two parallel screws (Olmed).
  2. Hemiarthroplasty with Charnley/ Hastings prosthesis.

A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Displaced femoral neck fracture
  • Age 60 or above
  • Able to walk (any aids allowed)

Exclusion Criteria:

  • Anesthesiologically unfit for arthroplasty surgery
  • Previous symptomatic hip pathology (i.e. arthritis)
  • Pathological fracture
  • Delay of more than 96 hours from injury to treatment
  • Not living in hospital area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Internal fixation
Closed reduction and internal fixation with two parallel screws (Olmed)
Procedure: Internal fixation
Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)
Other Names:
  • Olmed (DePuy)
OTHER: Bipolar hemiarthroplasty
Hemiarthroplasty with Charnley/ Hastings prosthesis
Procedure: Bipolar hemiarthroplasty
Lateral approach. FWB.
Other Names:
  • Charnley/Hastings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Harris Hip Score
Time Frame: 5-6 years
5-6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Eq-5d
Time Frame: 5-6 years
5-6 years
Barthel Index
Time Frame: 5-6 years
5-6 years
Reoperations and complications
Time Frame: 5-6 years
5-6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Collaborators

The Research Council of Norway
Norwegian Foundation for Health and Rehabilitation

Investigators

  • Study Chair: Jan Erik Madsen, MD PhD, Orthopedic Center, Ulleval University Hospital, Oslo, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (ESTIMATE)

October 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-2005-OS-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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