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

Femur Fracture Clinical Trial

— THA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01484405
• Other study ID #: THA
• Status: Terminated
• Phase: N/A
• First received: November 30, 2011
• Last updated: November 10, 2014
• Start date: June 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: Florida Orthopaedic Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Femoral Neck Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Procedure:
• posterior approach
Surgical approach for Total Hip Arthroplasty
• anterolateral approach
anterolateral surgical approach

Locations

Country	Name	City	State
United States	St Josephs Hospital	Tampa	Florida
United States	Tampa general Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Orthopaedic Institute	Orthopaedic Trauma Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dislocation rates	Radiographic variables: AP and lateral views of hip and pelvis	12 months	No
Secondary	other complications	Hospital readmission, reoperation	12 months	No