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Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures

Primary Purpose

Hip Fractures, Femoral Neck Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Direct Anterior Approach Hemiarthroplasty
Mini Posterior Approach
Lateral approach
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring hip, fractures, surgical approach, outcome, bleeding

Eligibility Criteria

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

Inclusion Criteria:

  • Consecutive patients undergoing hip fracture surgery for displaced femoral neck fractures (Garden 3 and 4 fractures) and treated by cemented hemiarthroplasty will be included in the study. Patients must have the ability to give informed consent or a legal guardian is available.

Exclusion Criteria:

  • The exclusion criteria include open or pathological fractures, re-fractures, infection, concomitant injuries of the ipsi- or contralateral leg or upper limb, skin diseases in the area of proposed incisions, patients that are mentally incapable of understanding the consequences of the study and reduced compliance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Direct anterior approach

    Mini Posterior Approach

    Lateral approach

    Arm Description

    Patients with a femoral neck fracture, treated by hemiarthroplasty by direct anterior approach, using a regular OR table, without hip hyperextension.

    Patients with a femoral neck fracture, treated by hemiarthroplasty by a mini posterior approach.

    Patients with a femoral neck fracture, treated by hemiarthroplasty by a lateral (Hardinge) approach.

    Outcomes

    Primary Outcome Measures

    The Five Item Barthel Index
    Patient mobilization and motoric status measured with a five-item-Barthel index. The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.
    The Five Item Barthel Index
    Patient mobilization and motoric status measured with a five-item-Barthel index. The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.
    The Timed Up and Go test (TUG)
    The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility. Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.
    The Timed Up and Go test (TUG)
    The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility. Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.
    Parker mobility score
    Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ). The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)
    Parker mobility score
    Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ). The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)

    Secondary Outcome Measures

    Change to the Total blood loss (TBL)
    For calculation of the total blood loss (TBL) expressed to total Hb loss and total Volume loss , we will use the number of transfusions (55 grams of haemoglobin per transfusion), the haemoglobin concentration on preoperatively (Hgbi) and the haemoglobin concentration on the last available measure of haemoglobin concentration (Hgbe). (Hemoglobin balance method)
    Change at the Pain Visual Analog (VAS) score
    The pain visual analog scale (VAS) is commonly used as the outcome measure for pain. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" (0 pain) and "worst pain imaginable." (100 pain)
    Muscle Damage Markers
    CK (Creatine Kinase), ECR and CRP
    Change at Creatine Kinase (CK)
    The appearance of creatine kinase (CK) in blood has been generally considered to be an indirect marker of muscle damage. Reference Values Males >3 months: 39-308 U/L Females >3 months: 26-192 U/L
    Change at C-Reactive protein (CRP)
    C-reactive protein (CRP) levels have been documented as a potent marker for skeletal muscle damage. Reference Value: 0-10mg/L

    Full Information

    First Posted
    June 17, 2020
    Last Updated
    October 31, 2020
    Sponsor
    National and Kapodistrian University of Athens
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04618549
    Brief Title
    Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures
    Official Title
    Direct Anterior Approach (in Regular OR Table) Versus Mini Posterior Approach Versus Lateral Approach for the Treatment of Displaced Femoral Neck Fractures: A Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    December 30, 2021 (Anticipated)
    Study Completion Date
    March 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National and Kapodistrian University of Athens

    4. Oversight

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

    5. Study Description

    Brief Summary
    In general, hip fractures in the elderly are associated with a high one year-mortality up to 36 %. Apart from choosing the proper treatment, optimizing the surgical technique itself offers options to improve the outcome. Early mobilization after hip hemi¬arthroplasty correlates with improved ambulation, reduced need for assisted transfers, and less use of extended care facilities after hospital discharge. Nowadays, in order to reduce soft tissue damage and gain quicker postoperative recovery and faster rehabilitation, various MIS techniques have been proposed. Two of these techniques are the mini posterior approach and the mini direct anterior approach. The direct anterior approach was developed as a true internervous and intermuscular surgical approach with proposed benefits of faster recovery, quicker return to function, and less pain. In theory, the direct anterior approach should cause less tissue damage than mini posterior approach, as it is performed through a plane between neurlogical tissue and intermuscular plane without muscle transection. The aim of this study is to evaluate the clinical and radiological outcomes of the direct anterior approach for bipolar head endoprosthetic hemiarthroplasty in patients with displaced femoral neck fractures in comparison with the mini posterior approach and the traditional lateral approach, for the treatment of the same fractures. The investigators hypothesized that patients undergoing the direct anterior approach would have better clinical and radiological results in comparison with the mini posterior and lateral approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Fractures, Femoral Neck Fractures
    Keywords
    hip, fractures, surgical approach, outcome, bleeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Direct anterior approach
    Arm Type
    Active Comparator
    Arm Description
    Patients with a femoral neck fracture, treated by hemiarthroplasty by direct anterior approach, using a regular OR table, without hip hyperextension.
    Arm Title
    Mini Posterior Approach
    Arm Type
    Active Comparator
    Arm Description
    Patients with a femoral neck fracture, treated by hemiarthroplasty by a mini posterior approach.
    Arm Title
    Lateral approach
    Arm Type
    Active Comparator
    Arm Description
    Patients with a femoral neck fracture, treated by hemiarthroplasty by a lateral (Hardinge) approach.
    Intervention Type
    Procedure
    Intervention Name(s)
    Direct Anterior Approach Hemiarthroplasty
    Intervention Description
    Hemiarthroplasty to elderly patients with femoral neck fracture through a direct anterior approach
    Intervention Type
    Procedure
    Intervention Name(s)
    Mini Posterior Approach
    Intervention Description
    Hemiarthroplasty to elderly patients with femoral neck fracture through a mini posterior approach
    Intervention Type
    Procedure
    Intervention Name(s)
    Lateral approach
    Intervention Description
    Hemiarthroplasty to elderly patients with femoral neck fracture through a lateral approach (Hardinge)
    Primary Outcome Measure Information:
    Title
    The Five Item Barthel Index
    Description
    Patient mobilization and motoric status measured with a five-item-Barthel index. The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.
    Time Frame
    6 weeks post-surgery
    Title
    The Five Item Barthel Index
    Description
    Patient mobilization and motoric status measured with a five-item-Barthel index. The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.
    Time Frame
    3 months post-surgery
    Title
    The Timed Up and Go test (TUG)
    Description
    The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility. Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.
    Time Frame
    4 days after the surgery
    Title
    The Timed Up and Go test (TUG)
    Description
    The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility. Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.
    Time Frame
    6 weeks post surgery
    Title
    Parker mobility score
    Description
    Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ). The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)
    Time Frame
    One week before the fracture occur
    Title
    Parker mobility score
    Description
    Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ). The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)
    Time Frame
    3 months post surgery
    Secondary Outcome Measure Information:
    Title
    Change to the Total blood loss (TBL)
    Description
    For calculation of the total blood loss (TBL) expressed to total Hb loss and total Volume loss , we will use the number of transfusions (55 grams of haemoglobin per transfusion), the haemoglobin concentration on preoperatively (Hgbi) and the haemoglobin concentration on the last available measure of haemoglobin concentration (Hgbe). (Hemoglobin balance method)
    Time Frame
    Preop to day 4 post surgery
    Title
    Change at the Pain Visual Analog (VAS) score
    Description
    The pain visual analog scale (VAS) is commonly used as the outcome measure for pain. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" (0 pain) and "worst pain imaginable." (100 pain)
    Time Frame
    From day one up to 6 weeks post surgery
    Title
    Muscle Damage Markers
    Description
    CK (Creatine Kinase), ECR and CRP
    Time Frame
    Daily for days 1-4 Post-op
    Title
    Change at Creatine Kinase (CK)
    Description
    The appearance of creatine kinase (CK) in blood has been generally considered to be an indirect marker of muscle damage. Reference Values Males >3 months: 39-308 U/L Females >3 months: 26-192 U/L
    Time Frame
    Daily for days 1-4 Post-op and at 6 weeks post-op
    Title
    Change at C-Reactive protein (CRP)
    Description
    C-reactive protein (CRP) levels have been documented as a potent marker for skeletal muscle damage. Reference Value: 0-10mg/L
    Time Frame
    Daily for days 1-4 Post-op and at 6 weeks post-op

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Consecutive patients undergoing hip fracture surgery for displaced femoral neck fractures (Garden 3 and 4 fractures) and treated by cemented hemiarthroplasty will be included in the study. Patients must have the ability to give informed consent or a legal guardian is available. Exclusion Criteria: The exclusion criteria include open or pathological fractures, re-fractures, infection, concomitant injuries of the ipsi- or contralateral leg or upper limb, skin diseases in the area of proposed incisions, patients that are mentally incapable of understanding the consequences of the study and reduced compliance.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vasileios S Nikolaou, MD, PhD, MSc
    Phone
    +306932543400
    Email
    vassilios.nikolaou@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures

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