Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Unknown status

CT.gov ID

NCT04311125

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis Hip Arthropathy Minimal Invasive Anterior Approach Tissue Injury	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

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

Imaging [Day 30 after surgery]
All patients will be subjected to imaging with a hip MRI
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2nd Department of Orthopaedics	Athens	Attika	Greece	14233

Sponsors and Collaborators

National and Kapodistrian University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vasileios S. Nikolaou, Associate Professor of Orthopaedics, National and Kapodistrian University of Athens

ClinicalTrials.gov Identifier:

NCT04311125

Other Study ID Numbers:

First Posted:

Mar 17, 2020

Last Update Posted:

Mar 17, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis, Hip

Study Results

No Results Posted as of Mar 17, 2020