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Status unknownNCT04673747Updated Jun 16, 2021

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

An interventional study of Total Hip Arthroplasty and Manual correction of the sacroiliac joint in Total Hip Arthroplasty, sponsored by I.M. Sechenov First Moscow State Medical University. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-16.

Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Jun 2017, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Total Hip Arthroplasty

Keywords

  • hip joint
  • the sacroiliac joint
  • Iliosacral displacement
  • manual correction
03

In context

Lead sponsor

I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • 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 · Procedure: Manual correction of the sacroiliac joint

  • Active comparator
    Group 2 (Total hip Arthroplasty: standard method)

    Patients will undergo total hip arthroplasty according to the standard method

    Procedure: Total Hip Arthroplasty

Interventions

  • ProcedureTotal Hip Arthroplasty

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

  • ProcedureManual 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: before surgery

  2. 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)

    Time frame: 3 months after surgery

  3. 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)

    Time frame: 6 months after surgery

  4. 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)

    Time frame: 12 months after surgery

  5. 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.

    Time frame: before surgery

  6. 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.

    Time frame: 3 months after surgery

  7. 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.

    Time frame: 6 months after surgery

  8. 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.

    Time frame: 12 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Sechenov University
    Moscow, 119991, Russian Federation
    Recruiting
08

References and documents

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 Apr;46(4):929. doi: 10.1007/s00264-021-05297-7. PubMed 34655319 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04673747
Lead sponsor
I.M. Sechenov First Moscow State Medical University
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Jun 1, 2017
Primary completion
May 2022 (estimated)
Completion
May 2022 (estimated)
Last update
Jun 16, 2021

Study contacts

Vadim Cherepanov, MD, PhD
Contact
cvg_cherepanov@mail.ru
+79166548850
Ivan Vyazankin, MD
Contact
vzvzvzvan@mail.ru
+79163770457
Alexey Lychagin, MD, Phd
study chair · IM Sechenov University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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