Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official title:

Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty: a Biochemical, Imaging and Clinical Evaluation in the Early Postoperative Period

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04311125
• Other study ID #: 4
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2020
• Source: National and Kapodistrian University of Athens
• Contact: Vasileios Nikolaou
• Phone: +306932543400
• Email: vassilios.nikolaou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Approach
• Hip Arthropathy
• Hip Osteoarthritis
• Joint Diseases
• Minimal Invasive
• Osteoarthritis, Hip
• Tissue Injury

Intervention

Procedure:
• Mini posterior approach Total Hip Replacement
Total hip replacement in patients suffering from hip osteoarthritis using the mini posterior approach
• Anterior approach total hip replacement without a traction table
Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis without the aid of a traction table
• Anterior approach total hip replacement with a traction table
Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis with the aid of a traction table

Locations

Country	Name	City	State
Greece	2nd Department of Orthopaedics	Athens	Attika

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue damage change	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.	Change from 6 to 24 and then 48 hours post-surgery
Secondary	Imaging	All patients will be subjected to imaging with a hip MRI	Day 30 after surgery
Secondary	Clinical Tests change	All patients will be monitored postoperatively for the prescribed period and data will be recorded.	Change to clinical test from Day 2 to day 15 and then day 30 post-surgery