Intraoperative Manual Correction of Iliosacral Displacement of the Sacroiliac Joint in Total Hip Arthroplasty

Study Overview
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Brief Summary
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Degenerative changes in the hip joint, which are indications for operative treatment, are observed in more than 30% over the age of 50. In most cases, the development of a degenerative process in the hip joint is accompanied by changes in the sacroiliac joint. To improve the quality of life, relieve pain, improve the clinical outcomes of rehabilitation after total hip arthroplasty (THA), an integrated approach to treatment is required. The investigators have developed a technique for intraoperative manual correction of the ileosacral displacement of the sacroiliac joint during THA. This clinical study compares the use of this technique during THA and THA by standard method.

Official Title
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Intraoperative Manual Correction of Iliosacral Displacement of the Sacroiliac Joint in Total Hip Arthroplasty

Conditions
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Total Hip Arthroplasty

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty
* Procedure: Manual correction of the sacroiliac joint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent of the patient to participate in the study Patients with osteoarthritis of the hip joint. The opportunity for observation during the entire study period (12 months) Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations Exclusion Criteria: The refusal of a patient from surgery The presence of contraindications to surgery Severe forms of diabetes (glycosylated hemoglobin >9%) Previously performed surgeries on the lumbar spine Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb< 90g\l) The unwillingness of the patient to conscious cooperation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Total Hip Arthroplasty with intraoperative manual correction)<br>Patients will undergo total hip arthroplasty with intraoperative manual correction of Iliosacral displacement of the sacroiliac joint | Procedure: Total Hip Arthroplasty<br>* Total replacement of the head, femoral neck and acetabulum of the hip joint with specialized implants<br>Procedure: Manual correction of the sacroiliac joint<br>* Manual correction of the iliosacral displacement of the sacroiliac joint in total hip arthroplasty is performed in the operating room after anesthesia just before total hip arthroplasty. It is carried out according to the methodology developed by us.<br>|
| Active Comparator: Group 2 (Total hip Arthroplasty: standard method)<br>Patients will undergo total hip arthroplasty according to the standard method | Procedure: Total Hip Arthroplasty<br>* Total replacement of the head, femoral neck and acetabulum of the hip joint with specialized implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Visual Analogue Scale (VAS) - assessment or the severity of pain syndrome. The score is determined by measuring the distance (mm) on a 10 cm line between the no pain anchor point and the patient's mark, giving a value range from 0 to 100 (0 - min; 100- max) | before surgery | 
| Pain assessment | Visual Analogue Scale (VAS) - assessment or the severity of pain syndrome. The score is determined by measuring the distance (mm) on a 10 cm line between the no pain anchor point and the patient's mark, giving a value range from 0 to 100 (0 - min; 100- max) | 3 months after surgery | 
| Pain assessment | Visual Analogue Scale (VAS) - assessment or the severity of pain syndrome. The score is determined by measuring the distance (mm) on a 10 cm line between the no pain anchor point and the patient's mark, giving a value range from 0 to 100 (0 - min; 100- max) | 6 months after surgery | 
| Pain assessment | Visual Analogue Scale (VAS) - assessment or the severity of pain syndrome. The score is determined by measuring the distance (mm) on a 10 cm line between the no pain anchor point and the patient's mark, giving a value range from 0 to 100 (0 - min; 100- max) | 12 months after surgery | 
| Hip function assessment | The Harris Hip Score (HSS). The HHS is a measure of disfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | before surgery | 
| Hip function assessment | The Harris Hip Score (HSS). The HHS is a measure of disfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 3 months after surgery | 
| Hip function assessment | The Harris Hip Score (HSS). The HHS is a measure of disfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 6 months after surgery | 
| Hip function assessment | The Harris Hip Score (HSS). The HHS is a measure of disfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manual correction, hip joint, the sacroiliac joint, Iliosacral displacement