Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Femoral Fractures
Hip Fractures
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014