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Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population

Primary Purpose

Femoral Neck Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip Hemiarthroplasty
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures

Eligibility Criteria

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

Inclusion Criteria:

  • isolated displaced femoral neck fracture (AO type 31-B2 and 31 B3)
  • age≥65 years
  • preinjury ambulation with or without a gait aid
  • surgical intervention ≤ 48 hours after fracture.

Exclusion Criteria:

  • age <65 years
  • patients with other fractures or dislocations
  • wheelchair bound
  • >48 hours between fracture and surgery, presence or history of infection, active metastatic disease, previous ipsilateral hip prosthesis
  • active major psychiatric illness
  • active drug or alcohol abuse
  • BMI >40, and actively failing contralateral hip prosthesis.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Direct Anterior Approach

Anterolateral Approach

Arm Description

All patients receiving a hip hemiarthroplasty through a Direct Anterior Approach (DAA) will have their surgeries performed with the aid of fluoroscopy on an OSI Hana table that allows the operative limb to be manipulated through range of motion and traction while keeping the pelvis stabilized. This table also has a radiolucent platform about the pelvis, enabling the surgery to be fluoroscopically assisted. The incision for the DAA will extend from a proximal point about 2 cm distal and 2 cm lateral to the ASIS to a point 8-12 cm distal and slightly lateral to this.

All patients receiving a hip hemiarthroplasty through an the Anterolateral Approach (ALA) will have their surgeries performed on a standard OR table in a contralateral lateral decubitus position. With the leg in the position of sleep, a straight 8-12 cm incision will be made, centered over the greater trochanter and femoral shaft with 1/3 of the incision extending superior to the tip of the greater trochanter.

Outcomes

Primary Outcome Measures

Number of patients showing improvement using the Timed Up and Go (TUG) Test
Purpose of test is to assess mobility and will be administered by a nurse who is blinded to the surgical approach.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2016
Last Updated
January 5, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02959320
Brief Title
Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population
Official Title
A Randomized Clinical Trial of Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
June 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so we are setting out to determine the differences between them.
Detailed Description
Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). Compared to those who receive a THA, recipients of HA tend to be less active, more debilitated, and more dependent on gait aids and the care of others. In this population, the increased stability and decreased operating time associated with HA is thought to be more important than the minimal increase in function this population could achieve with THA. Additionally, cemented femoral stems in HA are thought to result in less pain, increased function, and less periprosthetic fracture risk when compared to cementless stems. With the relative pre-injury debility of the femoral neck fracture population, especially those receiving HA, it is important to optimize all aspects of patient care to allow them to participate in therapy and return them to their preoperative functional level as quickly as possible. Furthermore, any intervention in this population should minimize the physiologic insult of surgery as much as possible. In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so investigators are setting out to determine the differences between them.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Direct Anterior Approach
Arm Type
Active Comparator
Arm Description
All patients receiving a hip hemiarthroplasty through a Direct Anterior Approach (DAA) will have their surgeries performed with the aid of fluoroscopy on an OSI Hana table that allows the operative limb to be manipulated through range of motion and traction while keeping the pelvis stabilized. This table also has a radiolucent platform about the pelvis, enabling the surgery to be fluoroscopically assisted. The incision for the DAA will extend from a proximal point about 2 cm distal and 2 cm lateral to the ASIS to a point 8-12 cm distal and slightly lateral to this.
Arm Title
Anterolateral Approach
Arm Type
Active Comparator
Arm Description
All patients receiving a hip hemiarthroplasty through an the Anterolateral Approach (ALA) will have their surgeries performed on a standard OR table in a contralateral lateral decubitus position. With the leg in the position of sleep, a straight 8-12 cm incision will be made, centered over the greater trochanter and femoral shaft with 1/3 of the incision extending superior to the tip of the greater trochanter.
Intervention Type
Procedure
Intervention Name(s)
Hip Hemiarthroplasty
Intervention Description
This single-institution, prospective, randomized clinical trial will be performed on consecutive elderly patients admitted for surgical treatment of displaced femoral neck fractures with hemiarthroplasty (HA).
Primary Outcome Measure Information:
Title
Number of patients showing improvement using the Timed Up and Go (TUG) Test
Description
Purpose of test is to assess mobility and will be administered by a nurse who is blinded to the surgical approach.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: isolated displaced femoral neck fracture (AO type 31-B2 and 31 B3) age≥65 years preinjury ambulation with or without a gait aid surgical intervention ≤ 48 hours after fracture. Exclusion Criteria: age <65 years patients with other fractures or dislocations wheelchair bound >48 hours between fracture and surgery, presence or history of infection, active metastatic disease, previous ipsilateral hip prosthesis active major psychiatric illness active drug or alcohol abuse BMI >40, and actively failing contralateral hip prosthesis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cross W. William, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population

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