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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Florida Orthopaedic Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Florida Orthopaedic Institute
ClinicalTrials.gov Identifier:
NCT01484405
First received: November 30, 2011
Last updated: December 1, 2011
Last verified: November 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Radiographic variables: AP and lateral views of hip and pelvis


Secondary Outcome Measures:
  • other complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hospital readmission, reoperation


Estimated Enrollment: 64
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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: NCT01484405

Locations
United States, Florida
Tampa general Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Barbara Steverson, RN, MHA,    813-253-2068    bsteverson@floridaortho.com   
Contact: Mary Miller, RN    813 253 2068    mmiller@floridaortho.com   
Principal Investigator: D Watson, MD         
St Josephs Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Barbara Steverson, RN, MHA    813-253-2068    bsteverson@floridaortho.com   
Contact: Mary Miller, RN    813-253-2068    mmiller@floridaortho.com   
Sponsors and Collaborators
Florida Orthopaedic Institute
Orthopaedic Trauma Association
Investigators
Principal Investigator: David Watson, MD Florida Orthopaedic Institute
  More Information

No publications provided

Responsible Party: Florida Orthopaedic Institute
ClinicalTrials.gov Identifier: NCT01484405     History of Changes
Other Study ID Numbers: THA
Study First Received: November 30, 2011
Last Updated: December 1, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 20, 2014