We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture (THA)

This study has been terminated.
(Low enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01484405
First Posted: December 2, 2011
Last Update Posted: November 11, 2014
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.
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Florida Orthopaedic Institute
  Purpose

There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement.

Null Hypothesis : There is no difference in complication rate, functional outcome, surgical time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or ORIF for femoral neck fractures.


Condition Intervention
Femur Fracture Procedure: posterior approach Procedure: anterolateral approach

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture

Resource links provided by NLM:


Further study details as provided by Florida Orthopaedic Institute:

Primary Outcome Measures:
  • dislocation rates [ Time Frame: 12 months ]
    Radiographic variables: AP and lateral views of hip and pelvis


Secondary Outcome Measures:
  • other complications [ Time Frame: 12 months ]
    Hospital readmission, reoperation


Enrollment: 16
Study Start Date: June 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
anterolateral approach
surgical intervention THA anterolateral approach
Procedure: anterolateral approach
anterolateral surgical approach
Other Name: Total hip Athroplasty following fracture
posterior approach
surgical intervention THA posterior approach
Procedure: posterior approach
Surgical approach for Total Hip Arthroplasty
Other Name: Total hip Athroplasty following fracture

Detailed Description:
Patients undergoing Total hip Arthroplasty following displaced femoral neck fracture, will be consented and randomized to one of two surgical approaches ( anterior or posterior).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Displaced femoral neck fracture
  • Age 65 years or older
  • Acute, femoral neck fracture

Exclusion Criteria:

Cognitive impairment

  • Active Infection
  • Limited functional capacity (nursing home resident, non-ambulatory, severe cardiorespiratory disease)
  • Limited life expectancy
  • Pathologic fracture (tumor)
  • Acetabular fractures
  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): NCT01484405


Locations
United States, Florida
Tampa general Hospital
Tampa, Florida, United States, 33606
St Josephs Hospital
Tampa, Florida, United States, 33607
Sponsors and Collaborators
Florida Orthopaedic Institute
Orthopaedic Trauma Association
Investigators
Principal Investigator: David Watson, MD Florida Orthopaedic Institute
  More Information

Responsible Party: Florida Orthopaedic Institute
ClinicalTrials.gov Identifier: NCT01484405     History of Changes
Other Study ID Numbers: THA
First Submitted: November 30, 2011
First Posted: December 2, 2011
Last Update Posted: November 11, 2014
Last Verified: November 2014

Keywords provided by Florida Orthopaedic Institute:
surgical approach for total hip arthroplasty

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