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

Not Applicable

• Conditions: Total Hip Arthroplasty
• Interventions: Procedure: Total Hip Arthroplasty; Procedure: Manual correction of the sacroiliac joint

• Registration Number: NCT04673747
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2020-11
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (Total hip Arthroplasty: standard method)	Total Hip Arthroplasty	Patients will undergo total hip arthroplasty according to the standard method
Group 1 (Total Hip Arthroplasty with intraoperative manual correction)	Total Hip Arthroplasty	Patients will undergo total hip arthroplasty with intraoperative manual correction of Iliosacral displacement of the sacroiliac joint
Group 1 (Total Hip Arthroplasty with intraoperative manual correction)	Manual correction of the sacroiliac joint	Patients will undergo total hip arthroplasty with intraoperative manual correction of Iliosacral displacement of the sacroiliac joint

Primary Outcome Measures

Name	Time	Method
Hip function assessment	12 months after surgery	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.
Pain assessment	12 months after surgery	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)

Trial Locations

Locations (1)

Sechenov University; 🇷🇺 Moscow, Russian Federation