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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Arthropathy of Hip
• Intervention / Treatment: Procedure: hip replacement

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hip arthritis

Exclusion Criteria:

• BMI>35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome of direct hip approach	Harry's hip score, a clinical score used in orthopedic surgery to describe outcome of hip function	32 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	32 months
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	32 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Bolognini di Seriate Bergamo

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: December 31, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 31, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: AObolognini1