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Clinical Trials/NCT02959320
NCT02959320
Completed
N/A

A Randomized Clinical Trial of Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population

Mayo Clinic1 site in 1 country69 target enrollmentNovember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Femoral Neck Fractures
Sponsor
Mayo Clinic
Enrollment
69
Locations
1
Primary Endpoint
Number of patients showing improvement using the Timed Up and Go (TUG) Test
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
June 2, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William W. Cross, III M.D.

Assistant Professor of Orthopedics,

Mayo Clinic

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.

Outcomes

Primary Outcomes

Number of patients showing improvement using the Timed Up and Go (TUG) Test

Time Frame: Baseline to 12 months

Purpose of test is to assess mobility and will be administered by a nurse who is blinded to the surgical approach.

Study Sites (1)

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