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

NCT ID: NCT04673747

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-05-31

Brief Summary

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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

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Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Total Hip Arthroplasty

Intervention Type PROCEDURE

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

Manual correction of the sacroiliac joint

Intervention Type 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 2 (Total hip Arthroplasty: standard method)

Patients will undergo total hip arthroplasty according to the standard method

Group Type ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type PROCEDURE

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

Interventions

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Total Hip Arthroplasty

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexey Lychagin, MD, Phd

Role: STUDY_CHAIR

IM Sechenov University

Locations

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Sechenov University

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Vadim Cherepanov, MD, PhD

Role: CONTACT

+79166548850

Ivan Vyazankin, MD

Role: CONTACT

+79163770457

Facility Contacts

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Vadim Cherepanov, MD, PHD

Role: primary

+79166548850

Ivan Vyazankin, MD

Role: backup

+79163770457

References

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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.

Reference Type DERIVED
PMID: 34655319 (View on PubMed)

Other Identifiers

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1381

Identifier Type: -

Identifier Source: org_study_id

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