Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 8 of 1650 for:    "Mayo Clinic" [Exact]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
William W. Cross, III M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02959320
First received: November 7, 2016
Last updated: November 18, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Femoral Neck Fractures
Procedure: Hip Hemiarthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of patients showing improvement using the Timed Up and Go (TUG) Test [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    Purpose of test is to assess mobility and will be administered by a nurse who is blinded to the surgical approach.


Estimated Enrollment: 142
Study Start Date: November 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: 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).
Active Comparator: 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.
Procedure: 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).

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.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02959320

Contacts
Contact: Joseph M. Statz, M.D. statz.joseph@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Joseph M. Statz, M.D.       statz.joseph@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Cross W. William, M.D. Mayo Clinic
  More Information

Responsible Party: William W. Cross, III M.D., Assistant Professor of Orthopedics,, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02959320     History of Changes
Other Study ID Numbers: 16-003695 
Study First Received: November 7, 2016
Last Updated: November 18, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on December 02, 2016