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

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ClinicalTrials.gov Identifier: NCT02645435
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo

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.


Condition or disease Intervention/treatment Phase
Arthropathy of Hip Surgery Procedure: hip replacement Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement
Study Start Date : December 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: Hip direct anterior approach
Patients with hip arthritis
Procedure: hip replacement
Total hip replacement

Active Comparator: Lateral hip approach
Patients with hip arthritis
Procedure: hip replacement
Total hip replacement




Primary Outcome Measures :
  1. Clinical outcome of direct hip approach [ Time Frame: 32 months ]
    Harry's hip score, a clinical score used in orthopedic surgery to describe outcome of hip function


Secondary Outcome Measures :
  1. radiological positioning of cup in the replaced hip [ Time Frame: 32 months ]
    using standard x-ray of the hip placement of implants is measured in angles between the iliac line and component line for the cup

  2. radiological positioning of the stem in replaced hip [ Time Frame: 32 months ]
    using standard x-ray of the hip placement of implants is measured in angles between the axis of implant and femoral axis



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hip arthritis

Exclusion Criteria:

  • BMI>35

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Responsible Party: Riccardo Compagnoni, Medical Doctor, Azienda Ospedaliera Bolognini di Seriate Bergamo
ClinicalTrials.gov Identifier: NCT02645435     History of Changes
Other Study ID Numbers: AObolognini1
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases