Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

Not Applicable

• Conditions: Tissue Injury; Hip Arthropathy; Hip Osteoarthritis; Minimal Invasive; Anterior Approach

• Registration Number: NCT04311125
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

Total hip arthroplasty is a method of choice for treating advanced osteoarthritis of the hip and one of the most frequent orthopedic procedures. Of all hip surgical approaches described, the tendency for minimally invasive techniques has been dominated over the last few years due to faster patient mobilization, reduced postoperative pain and need for blood transfusion. Two of the most common approaches used for minimally invasive total hip arthroplasty are: AMIS anterior approach and mini-posterior approach, which is a modification of the standard posterior approach. The purpose of this study is the biochemical, imaging and clinical evaluation of the tissue damage caused by the above-mentioned techniques of minimally invasive total hip arthroplasty.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-14
• Last Update Submitted: 2020-03-14
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17
• Study Start: 2020-04-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients that sign the Informed consent
• Patients aged 18 years and over who are going to undergo primary total hip arthroplasty

Exclusion Criteria

I. Active infection II. Previous hip operation in any leg III. Any kind of operation the past 3 months IV. Obesity (BMI, Body Mass Index >30) V. Autoimmune diseases or myositis of any etiology VI. Active cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tissue damage change	Change from 6 to 24 and then 48 hours post-surgery	Investigate and quantify at the biochemical level with all available biomarkers the extent of tissue damage caused during a hip arthroplasty between different hip surgical approaches.

Secondary Outcome Measures

Name	Time	Method
Clinical Tests change	Change to clinical test from Day 2 to day 15 and then day 30 post-surgery	All patients will be monitored postoperatively for the prescribed period and data will be recorded.
Imaging	Day 30 after surgery	All patients will be subjected to imaging with a hip MRI

Trial Locations

Locations (1)

2nd Department of Orthopaedics; 🇬🇷 Athens, Attika, Greece