Clinical trial NCT04673747: Intraoperative Manual Correction of Iliosacral Displacement of the Sacroiliac Joint in Total Hip Arthroplasty
Official title: Intraoperative Manual Correction of Iliosacral Displacement of the Sacroiliac Joint in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: hip joint
the sacroiliac joint
Iliosacral displacement
manual correction
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain assessment
timeFrame: before surgery
measure: Pain assessment
timeFrame: 3 months after surgery
measure: Pain assessment
timeFrame: 6 months after surgery
measure: Pain assessment
timeFrame: 12 months after surgery
measure: Hip function assessment
timeFrame: before surgery
measure: Hip function assessment
timeFrame: 3 months after surgery
measure: Hip function assessment
timeFrame: 6 months after surgery
measure: Hip function assessment
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
affiliation: IM Sechenov University
name: Alexey Lychagin, MD, Phd
role: STUDY_CHAIR
References:
citation: 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.