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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT01344772
First received: April 28, 2011
Last updated: November 23, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Danderyd Hospital:

Primary Outcome Measures:
  • Harris hip score [ Time Frame: 17 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Olof Skoldenberg, Consulatant Orthopaedic Surgeon, PhD, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01344772     History of Changes
Other Study ID Numbers: 19902010
Study First Received: April 28, 2011
Last Updated: November 23, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014