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

Primary Purpose

Femur Fracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
posterior approach
anterolateral approach
Sponsored by
Florida Orthopaedic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femur Fracture focused on measuring surgical approach for total hip arthroplasty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampa general Hospital
  • St Josephs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

anterolateral approach

posterior approach

Arm Description

surgical intervention THA anterolateral approach

surgical intervention THA posterior approach

Outcomes

Primary Outcome Measures

dislocation rates
Radiographic variables: AP and lateral views of hip and pelvis

Secondary Outcome Measures

other complications
Hospital readmission, reoperation

Full Information

First Posted
November 30, 2011
Last Updated
November 10, 2014
Sponsor
Florida Orthopaedic Institute
Collaborators
Orthopaedic Trauma Association
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1. Study Identification

Unique Protocol Identification Number
NCT01484405
Brief Title
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture
Acronym
THA
Official Title
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment.
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida Orthopaedic Institute
Collaborators
Orthopaedic Trauma Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture
Keywords
surgical approach for total hip arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anterolateral approach
Arm Type
Other
Arm Description
surgical intervention THA anterolateral approach
Arm Title
posterior approach
Arm Type
Other
Arm Description
surgical intervention THA posterior approach
Intervention Type
Procedure
Intervention Name(s)
posterior approach
Other Intervention Name(s)
Total hip Athroplasty following fracture
Intervention Description
Surgical approach for Total Hip Arthroplasty
Intervention Type
Procedure
Intervention Name(s)
anterolateral approach
Other Intervention Name(s)
Total hip Athroplasty following fracture
Intervention Description
anterolateral surgical approach
Primary Outcome Measure Information:
Title
dislocation rates
Description
Radiographic variables: AP and lateral views of hip and pelvis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
other complications
Description
Hospital readmission, reoperation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Watson, MD
Organizational Affiliation
Florida Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa general Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
St Josephs Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States

12. IPD Sharing Statement

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

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