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

NCT02959320 | Completed

• 1 other identifier: 16-003695
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 months

Study Arms (2)

Direct Anterior Approach

ACTIVE COMPARATOR

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.

Procedure: Hip Hemiarthroplasty

Anterolateral Approach

ACTIVE COMPARATOR

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.

Procedure: Hip Hemiarthroplasty

Interventions

Hip Hemiarthroplasty 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; Direct Anterior Approach

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Cross W. William, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedics,

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: November 1, 2016
• Primary Completion: September 7, 2021
• Study Completion: June 2, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)