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

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.

Study Overview

• Status: Terminated
• Conditions: Femur Fracture
• Intervention / Treatment: Procedure: anterolateral approach; Procedure: posterior approach

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
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33607
      • St Josephs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: anterolateral approach; surgical intervention THA anterolateral approach	Procedure: anterolateral approach; anterolateral surgical approach; Other Names: Total hip Athroplasty following fracture
Other: posterior approach; surgical intervention THA posterior approach	Procedure: posterior approach; Surgical approach for Total Hip Arthroplasty; Other Names: Total hip Athroplasty following fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dislocation rates	Radiographic variables: AP and lateral views of hip and pelvis	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
other complications	Hospital readmission, reoperation	12 months

Collaborators and Investigators

• Sponsor: Florida Orthopaedic Institute
• Collaborators: Orthopaedic Trauma Association
• Investigators: Principal Investigator: David Watson, MD, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 30, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Estimate): November 11, 2014
• Last Update Submitted That Met QC Criteria: November 10, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: surgical approach for total hip arthroplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Hip Fractures; Femoral Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: THA