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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645435
• Other study ID #: AObolognini1
• Status: Completed
• Phase: Phase 4
• First received: December 29, 2015
• Last updated: December 31, 2015
• Start date: December 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Azienda Ospedaliera Bolognini di Seriate Bergamo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hip arthritis

Exclusion Criteria:

• BMI>35

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthropathy of Hip
• Surgery

Intervention

Procedure:
• hip replacement
Total hip replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Bolognini di Seriate Bergamo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No