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

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04673747
• Other study ID #: 1381
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 2022

Study information

• Verified date: November 2020
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Vadim Cherepanov, MD, PhD
• Phone: +79166548850
• Email: cvg_cherepanov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• Total Hip Arthroplasty
Total replacement of the head, femoral neck and acetabulum of the hip joint with specialized implants
• 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.

Locations

Country	Name	City	State
Russian Federation	Sechenov University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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