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

November 30, 2011
December 1, 2011
June 2010
June 2013   (final data collection date for primary outcome measure)
dislocation rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Radiographic variables: AP and lateral views of hip and pelvis
Same as current
Complete list of historical versions of study NCT01484405 on ClinicalTrials.gov Archive Site
other complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Hospital readmission, reoperation
Same as current
Not Provided
Not Provided
 
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Femur Fracture
  • Procedure: posterior approach
    Surgical approach for Total Hip Arthroplasty
    Other Name: Total hip Athroplasty following fracture
  • Procedure: anterolateral approach
    anterolateral surgical approach
    Other Name: Total hip Athroplasty following fracture
  • anterolateral approach
    surgical intervention THA anterolateral approach
    Intervention: Procedure: anterolateral approach
  • posterior approach
    surgical intervention THA posterior approach
    Intervention: Procedure: posterior approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Not Provided
United States
 
NCT01484405
THA
No
Florida Orthopaedic Institute
Florida Orthopaedic Institute
Orthopaedic Trauma Association
Principal Investigator: David Watson, MD Florida Orthopaedic Institute
Florida Orthopaedic Institute
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP