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

NCT ID: NCT02959320

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-06-02

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.

Conditions

Femoral Neck Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Direct Anterior Approach

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.

Group Type: ACTIVE_COMPARATOR

Hip Hemiarthroplasty

Intervention Type: PROCEDURE

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).

Anterolateral Approach

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.

Group Type: ACTIVE_COMPARATOR

Hip Hemiarthroplasty

Intervention Type: PROCEDURE

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).

Interventions

Hip Hemiarthroplasty

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).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

William W. Cross, III M.D.

Assistant Professor of Orthopedics,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cross W. William, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

16-003695

Identifier Type: -

Identifier Source: org_study_id