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

NCT04673747 | Unknown DMC

• 1 other identifier: 1381
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Keywords

hip joint; the sacroiliac joint; Iliosacral displacement; manual correction

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Group 1 (Total Hip Arthroplasty with intraoperative manual correction)

EXPERIMENTAL

Patients will undergo total hip arthroplasty with intraoperative manual correction of Iliosacral displacement of the sacroiliac joint

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

Group 2 (Total hip Arthroplasty: standard method)

ACTIVE COMPARATOR

Patients will undergo total hip arthroplasty according to the standard method

Procedure: Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty PROCEDURE

Total replacement of the head, femoral neck and acetabulum of the hip joint with specialized implants

Group 1 (Total Hip Arthroplasty with intraoperative manual correction); Group 2 (Total hip Arthroplasty: standard method)

Manual correction of the sacroiliac joint PROCEDURE

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.

Group 1 (Total Hip Arthroplasty with intraoperative manual correction)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov University

Moscow, 119991, Russia

RECRUITING

Related Publications (1)

• 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.

  PMID: 34655319 DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Alexey Lychagin, MD, Phd

  IM Sechenov University

  STUDY CHAIR

Central Study Contacts

Vadim Cherepanov, MD, PhD

CONTACT

+79166548850; cvg_cherepanov@mail.ru

Ivan Vyazankin, MD

CONTACT

+79163770457; vzvzvzvan@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2017
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 16, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)