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

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.

Study Overview

• Status: Unknown
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Procedure: Total Hip Arthroplasty; Procedure: Manual correction of the sacroiliac joint

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Sechenov University
    • Contact: Vadim Cherepanov, MD, PHD; Phone Number: +79166548850; Email: cvg_cherepanov@mail.ru
    • Contact: Ivan Vyazankin, MD; Phone Number: +79163770457; Email: vzvzvzvan@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Total Hip Arthroplasty with intraoperative manual correction); Patients will undergo total hip arthroplasty with intraoperative manual correction of Iliosacral displacement of the sacroiliac joint	Procedure: Total Hip Arthroplasty; Total replacement of the head, femoral neck and acetabulum of the hip joint with specialized implants; Procedure: Manual correction of the sacroiliac joint; 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.
Active Comparator: Group 2 (Total hip Arthroplasty: standard method); Patients will undergo total hip arthroplasty according to the standard method	Procedure: Total Hip Arthroplasty; Total replacement of the head, femoral neck and acetabulum of the hip joint with specialized implants

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Study Chair: Alexey Lychagin, MD, Phd, IM Sechenov University

Publications and helpful links

General Publications

• Alexey L, Vadim C, Marina L, Evgenia T, Kseniya Y, Roza YH, Alexey K, Ivan V. Prognostic role of affected side of the sacroiliac joint in pain recurrence after total hip arthroplasty with prior manual correction of iliosacral dislocation: prospective randomized clinical study. Int Orthop. 2022 Mar;46(3):541-548. doi: 10.1007/s00264-021-05240-w. Epub 2021 Oct 16. Erratum In: Int Orthop. 2022 Jan 19;:

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: hip joint; the sacroiliac joint; Iliosacral displacement; manual correction
• Other Study ID Numbers: 1381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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