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Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair

Primary Purpose

Hip Fractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical approach
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

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

Inclusion Criteria:

  • Any patient undergoing a hemiarthroplasty for a femoral neck fracture;
  • Patients capable of reading, writing and signing an informed consent form

Exclusion Criteria:

  • Patients under the age of 18

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Direct anterior approach for hemiarthroplasty

    Lateral approach for hemiarthroplasty

    Arm Description

    Patients in this arm will receive a hemiarthroplasty using the direct anterior approach (DAA)

    Patients in this arm will receive a hemiarthroplasty using the lateral approach

    Outcomes

    Primary Outcome Measures

    Short-term mobility
    The primary outcome measure will be mobility, assessed using the Short Physical Performance Battery (SPPB) test at post-operative day six or at discharge (4). This outcome assessed at this timeframe has been shown to be predictive of long-term function.

    Secondary Outcome Measures

    EuroQol 5
    Secondary outcomes measures will include evaluation of the patient's quality of life (using the EuroQol 5 questionnaire).
    Visual Analogue Scale
    The Visual Analogue Scale will be given to patients 2- weeks post op to assess their levels of pain.
    Opioid Use
    Opioid Use will be monitored for two weeks post-op via. phone calls and follow-up visits
    Barthel 20 Index
    Family will be asked to complete questionnaires if patients are unable to. Activities of daily living (Barthel 20) will be assessed at post-operative day six or at discharge, day 14, and week 6 by a physiotherapist or nurse.

    Full Information

    First Posted
    November 9, 2021
    Last Updated
    December 10, 2021
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05173155
    Brief Title
    Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair
    Official Title
    Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair: A Short-term Outcomes Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Recent research has demonstrated that a hemiarthroplasty (replacement of half the joint) has lower rates of post-surgical complications than a total hip arthroplasty does. However, surgeons tend to vary in their approach to hemiarthroplasties. The lateral approach, which involves making an incision at the side of the patient's hip, requires surgeons to cut through the muscle to access the hip, which has been associated with greater muscle damage and slower rates of recovery. On the other hand, the direct anterior approach does not require the cutting of the patient's muscle and is therefore associated with minimal muscle damage and faster rates of recovery. This study will aim to assess the impact of the surgical approach (Direct Anterior Approach vs. Lateral approach) during hemiarthroplasty on patients' short-term mobility, quality of life, function, pain, and safety parameters.
    Detailed Description
    Hip fractures continue to increase with the aging Canadian population. Overall clinical and functional outcomes following hip fractures are poor, with only a third of patients returning to their pre-injury functional status (1). The hemiarthroplasty, which involves replacing the femoral head with a prosthesis after femoral neck fracture, is the procedure of choice in most intra-capsular hip fractures (2). Similar to the total hip arthroplasty, the hemiarthroplasty has been shown to be a safe and effective surgical technique. A recent study found that the hemiarthroplasty was associated with lower incidence of serious adverse events when compared to total hip arthroplasty (3). Approaches to the hip used by surgeons to perform arthroplasty procedures may vary. The lateral approach has been advocated by National bodies to be the approach of choice in arthroplasties for hip fractures because it is associated with a smaller dislocation compared to the posterior approach. However, the lateral approach is associated with significant morbidity to the musculature about the hip, which is already weak and degenerate in this population. Thus, the lateral approach may further impede recovery of this frail population. An attractive alternative of a surgical approach for this population may be the Direct Anterior Approach to the hip. This is an inter-nervous and inter-muscular approach, associated with minimal muscle damage. Furthermore, stability (i.e. dislocation risk) has been reported to be at least equal to that reported with the lateral approach. However, the Direct Anterior Approach is an approach associated with a learning curve of at least 100 cases and a potential increased risk of infection and peri-prosthetic fracture. The Direct Anterior Approach has shown to have superior outcomes compared to the lateral approach in total hip arthroplasty studies, however, no study to-date has compared these approaches in the setting of hip fractures where the lateral approach is considered the gold standard. The investigators feel that this is an important question to answer and believe that The Ottawa Hospital has the appropriate expertise to conduct such study. Our center has utilized the Direct Anterior Approach in total hip arthroplasty for the last 10 years and the team's extensive experienced has been published. At present, 5 arthroplasty surgeons routinely perform the Direct Anterior Approach for at least half of their hip arthroplasty patients. Furthermore, 3 of the staff surgeons are considered key opinion leaders on the Direct Anterior Approach having mentored many surgeons nationally and internationally in many teaching formats including courses and invited lectures. The primary objective of this study is to assess the impact of the surgical approach for a hemiarthroplasty on patients' short-term mobility. The secondary objectives are to assess the impact of approach on quality of life, function, pain and safety parameters. We hypothesize that the Direct Anterior Approach will lead to superior function and mobility at short-term follow-up.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will either receive a hemiarthroplasty in the direct anterior approach or the lateral approach.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Direct anterior approach for hemiarthroplasty
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will receive a hemiarthroplasty using the direct anterior approach (DAA)
    Arm Title
    Lateral approach for hemiarthroplasty
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will receive a hemiarthroplasty using the lateral approach
    Intervention Type
    Procedure
    Intervention Name(s)
    surgical approach
    Intervention Description
    Comparison of short-term outcomes (patient mobility, quality of life, function, pain, and safety parameters) for the direct anterior approach and Lateral approach for hemiarthroplasty for patients who have experienced a femoral-neck hip fracture.
    Primary Outcome Measure Information:
    Title
    Short-term mobility
    Description
    The primary outcome measure will be mobility, assessed using the Short Physical Performance Battery (SPPB) test at post-operative day six or at discharge (4). This outcome assessed at this timeframe has been shown to be predictive of long-term function.
    Time Frame
    six days post-op
    Secondary Outcome Measure Information:
    Title
    EuroQol 5
    Description
    Secondary outcomes measures will include evaluation of the patient's quality of life (using the EuroQol 5 questionnaire).
    Time Frame
    2-weeks post-op
    Title
    Visual Analogue Scale
    Description
    The Visual Analogue Scale will be given to patients 2- weeks post op to assess their levels of pain.
    Time Frame
    2-weeks post-op
    Title
    Opioid Use
    Description
    Opioid Use will be monitored for two weeks post-op via. phone calls and follow-up visits
    Time Frame
    2-weeks post-op
    Title
    Barthel 20 Index
    Description
    Family will be asked to complete questionnaires if patients are unable to. Activities of daily living (Barthel 20) will be assessed at post-operative day six or at discharge, day 14, and week 6 by a physiotherapist or nurse.
    Time Frame
    ost-operative day six or at discharge, day 14, and week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Any patient undergoing a hemiarthroplasty for a femoral neck fracture; Patients capable of reading, writing and signing an informed consent form Exclusion Criteria: Patients under the age of 18

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair

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