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

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ClinicalTrials.gov Identifier: NCT01484405
Recruitment Status : Terminated (Low enrollment.)
First Posted : December 2, 2011
Last Update Posted : November 11, 2014
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Florida Orthopaedic Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Femur Fracture Procedure: posterior approach Procedure: anterolateral approach Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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


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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
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

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

Responsible Party: Florida Orthopaedic Institute
ClinicalTrials.gov Identifier: NCT01484405     History of Changes
Other Study ID Numbers: THA
First Posted: December 2, 2011    Key Record Dates
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