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Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement

Primary Purpose

Arthropathy of Hip, Surgery

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hip replacement
Sponsored by
Azienda Ospedaliera Bolognini di Seriate Bergamo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Hip

Eligibility Criteria

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

Inclusion Criteria:

  • Hip arthritis

Exclusion Criteria:

  • BMI>35

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Hip direct anterior approach

    Lateral hip approach

    Arm Description

    Patients with hip arthritis

    Patients with hip arthritis

    Outcomes

    Primary Outcome Measures

    Clinical outcome of direct hip approach
    Harry's hip score, a clinical score used in orthopedic surgery to describe outcome of hip function

    Secondary Outcome Measures

    radiological positioning of cup in the replaced hip
    using standard x-ray of the hip placement of implants is measured in angles between the iliac line and component line for the cup
    radiological positioning of the stem in replaced hip
    using standard x-ray of the hip placement of implants is measured in angles between the axis of implant and femoral axis

    Full Information

    First Posted
    December 29, 2015
    Last Updated
    December 31, 2015
    Sponsor
    Azienda Ospedaliera Bolognini di Seriate Bergamo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02645435
    Brief Title
    Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement
    Official Title
    Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliera Bolognini di Seriate Bergamo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement. Methods: The first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.
    Detailed Description
    Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement. Methods: The first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hip direct anterior approach
    Arm Type
    Active Comparator
    Arm Description
    Patients with hip arthritis
    Arm Title
    Lateral hip approach
    Arm Type
    Active Comparator
    Arm Description
    Patients with hip arthritis
    Intervention Type
    Procedure
    Intervention Name(s)
    hip replacement
    Intervention Description
    Total hip replacement
    Primary Outcome Measure Information:
    Title
    Clinical outcome of direct hip approach
    Description
    Harry's hip score, a clinical score used in orthopedic surgery to describe outcome of hip function
    Time Frame
    32 months
    Secondary Outcome Measure Information:
    Title
    radiological positioning of cup in the replaced hip
    Description
    using standard x-ray of the hip placement of implants is measured in angles between the iliac line and component line for the cup
    Time Frame
    32 months
    Title
    radiological positioning of the stem in replaced hip
    Description
    using standard x-ray of the hip placement of implants is measured in angles between the axis of implant and femoral axis
    Time Frame
    32 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hip arthritis Exclusion Criteria: BMI>35

    12. IPD Sharing Statement

    Learn more about this trial

    Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement

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