Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

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

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.

Study Overview

• Status: Unknown
• Conditions: Hip Osteoarthritis; Hip Arthropathy; Tissue Injury; Minimal Invasive; Anterior Approach
• Intervention / Treatment: Procedure: Mini posterior approach Total Hip Replacement; Procedure: Anterior approach total hip replacement without a traction table; Procedure: Anterior approach total hip replacement with a traction table

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attika
    • Athens, Attika, Greece, 14233
      • Recruiting
      • 2nd Department of Orthopaedics
      • Contact: Vasileios Nikolaou, MD, MSc, PhD; Phone Number: +306932543400; Email: vassilios.nikolaou@gmail.com
      • Sub-Investigator: Michael Sarantis, MD
      • Sub-Investigator: Panagiotis Mandrekas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: total hip arthroplasty via the mini posterior approach; 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; Total hip replacement in patients suffering from hip osteoarthritis using the mini posterior approach
Active Comparator: THR via the anterior approach without traction table; 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; Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis without the aid of a traction table
Active Comparator: THR via the anterior approach with a traction table; 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; Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis with the aid of a traction table

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging	All patients will be subjected to imaging with a hip MRI	Day 30 after surgery
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

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 14, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No