search
Back to results

Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

Primary Purpose

Hip Osteoarthritis, Hip Arthropathy, Minimal Invasive

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Mini posterior approach Total Hip Replacement
Anterior approach total hip replacement without a traction table
Anterior approach total hip replacement with a traction table
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

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

Sites / Locations

  • 2nd Department of OrthopaedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

total hip arthroplasty via the mini posterior approach

THR via the anterior approach without traction table

THR via the anterior approach with a traction table

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Imaging
All patients will be subjected to imaging with a hip MRI
Clinical Tests change
All patients will be monitored postoperatively for the prescribed period and data will be recorded.

Full Information

First Posted
March 10, 2020
Last Updated
March 14, 2020
Sponsor
National and Kapodistrian University of Athens
search

1. Study Identification

Unique Protocol Identification Number
NCT04311125
Brief Title
Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty
Official Title
Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty: a Biochemical, Imaging and Clinical Evaluation in the Early Postoperative Period
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Hip Arthropathy, Minimal Invasive, Anterior Approach, Tissue Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
total hip arthroplasty via the mini posterior approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
THR via the anterior approach without traction table
Arm Type
Active Comparator
Arm Description
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.
Arm Title
THR via the anterior approach with a traction table
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mini posterior approach Total Hip Replacement
Intervention Description
Total hip replacement in patients suffering from hip osteoarthritis using the mini posterior approach
Intervention Type
Procedure
Intervention Name(s)
Anterior approach total hip replacement without a traction table
Intervention Description
Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis without the aid of a traction table
Intervention Type
Procedure
Intervention Name(s)
Anterior approach total hip replacement with a traction table
Intervention Description
Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis with the aid of a traction table
Primary Outcome Measure Information:
Title
Tissue damage change
Description
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.
Time Frame
Change from 6 to 24 and then 48 hours post-surgery
Secondary Outcome Measure Information:
Title
Imaging
Description
All patients will be subjected to imaging with a hip MRI
Time Frame
Day 30 after surgery
Title
Clinical Tests change
Description
All patients will be monitored postoperatively for the prescribed period and data will be recorded.
Time Frame
Change to clinical test from Day 2 to day 15 and then day 30 post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vasileios Nikolaou
Phone
+306932543400
Email
vassilios.nikolaou@gmail.com
Facility Information:
Facility Name
2nd Department of Orthopaedics
City
Athens
State/Province
Attika
ZIP/Postal Code
14233
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasileios Nikolaou, MD, MSc, PhD
Phone
+306932543400
Email
vassilios.nikolaou@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael Sarantis, MD
First Name & Middle Initial & Last Name & Degree
Panagiotis Mandrekas, MD

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

We'll reach out to this number within 24 hrs