Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

NCT04311125 | Unknown

• 1 other identifier: 4
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis; Hip Arthropathy; Minimal Invasive; Anterior Approach; Tissue Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Imaging

  Day 30 after surgery

• Clinical Tests change

  Change to clinical test from Day 2 to day 15 and then day 30 post-surgery

Study Arms (3)

total hip arthroplasty via the mini posterior approach

ACTIVE COMPARATOR

total hip arthroplasty via the mini posterior approach. This approach was first described by Kocher and Langenbeck and later modified by Gibson in 1950. There is a convex incision centered on the posterior rim of the major trochanter. The incision follows the curve of the buttock and at the height of the posterior lip of the major trochanter, it is peripherally oriented along the posterior outer surface of the femur. The major gluteus is divided along the muscle fibers. Guiding sutures are inserted into the tendon mass of the hip rotor muscles just prior to their origin on the major trochanter and dissected to expose and subsequently retract the posterior hip capsule.

Procedure: Mini posterior approach Total Hip Replacement

THR via the anterior approach without traction table

ACTIVE COMPARATOR

The anterior approach is a modification of the classic Smith- Peterson anterior hip approach as described by Berend et al in 2009 \[7\]. This approach utilizes the intermuscular plane between the tendon fascia lata and the sartorius muscle, and laterally repairs the fibers of the rectus femur to expose and enclose the anterior pubic joint. A surgical traction table may be used during surgery.

Procedure: Anterior approach total hip replacement without a traction table

THR via the anterior approach with a traction table

ACTIVE COMPARATOR

The anterior approach is a modification of the classic Smith- Peterson anterior hip approach as described by Berend et al in 2009 \[7\]. This approach utilizes the intermuscular plane between the tendon fascia lata and the sartorius muscle, and laterally repairs the fibers of the rectus femur to expose and enclose the anterior pubic joint. A surgical traction table may be used during surgery.

Procedure: Anterior approach total hip replacement with a traction table

Interventions

Mini posterior approach Total Hip Replacement PROCEDURE

Total hip replacement in patients suffering from hip osteoarthritis using the mini posterior approach

total hip arthroplasty via the mini posterior approach

Anterior approach total hip replacement without a traction table PROCEDURE

Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis without the aid of a traction table

THR via the anterior approach without traction table

Anterior approach total hip replacement with a traction table PROCEDURE

Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis with the aid of a traction table

THR via the anterior approach with a traction table

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

2nd Department of Orthopaedics

Athens, Attica, 14233, Greece

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Vasileios Nikolaou

CONTACT

+306932543400; vassilios.nikolaou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

GR (1)