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Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344772
First Posted: April 29, 2011
Last Update Posted: November 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital
  Purpose
The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.

Condition Intervention
Femoral Neck Fracture Procedure: Internal fixation Procedure: Total hip arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck. A Randomized, Controlled Trial With a Seventeen Year Follow-up

Resource links provided by NLM:


Further study details as provided by Olof Skoldenberg, Danderyd Hospital:

Primary Outcome Measures:
  • Harris hip score [ Time Frame: 17 years ]
    HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function.


Secondary Outcome Measures:
  • Reoperations and complications [ Time Frame: 17 years ]

    IF group: nonunion, osteonecrosis, deep infection or fracture in the vicinity of the screws. Protruding screws or extraction of the screws when the fracture was healed was not defined as a complication.

    THR group: radiographic signs of loosening of the femoral- or acetabular component, dislocation, periprosthetic fracture or deep infection



Enrollment: 100
Study Start Date: February 1990
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Internal fixation
Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.
Procedure: Internal fixation
Two cannulated screws are placed under x-ray guidance
Active Comparator: Total hip replacement
Displaced femoral neck fracture treated with total hip replacement through a posterior approach.
Procedure: Total hip arthroplasty
A total hip arthroplasty is performed through a standard posterior approach

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute displaced femoral neck fracture Garden III or IV,
  • Age over 65 years,
  • Admission from their own home,
  • No concurrent joint disease or previous fracture in the lower extremities,
  • Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),
  • Harris hip score of 100
  • Acceptance from the patient to participate in the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344772


Locations
Sweden
Danderyd Hospital
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Danderyd Hospital
Investigators
Principal Investigator: Olof Sköldenberg, MD, PhD Danderyd Hospital
  More Information

Responsible Party: Olof Skoldenberg, Consulatant Orthopaedic Surgeon, PhD, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01344772     History of Changes
Other Study ID Numbers: 19902010
First Submitted: April 28, 2011
First Posted: April 29, 2011
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Olof Skoldenberg, Danderyd Hospital:
femoral neck fracture
total hip arthroplasty
internal fixation

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries