About this trial
Relevance and Rationale Due to the widespread development of high-tech medical care in traumatology and orthopedics for patients with severe forms of hip and knee osteoarthritis and aseptic necrosis, and the increasing number of knee and hip arthroplasties, there is a proportional increase in serious complications after arthroplasty, the most serious and costly of which is the development of peri-implant infection.
Today, the prevalence of peri-implant infection is close to epidemic. It is worth noting that peri-implant infection is not always associated with poor surgical technique or the quality of prostheses.
Often, the causes of this life-threatening complication are not fully understood. Currently, no large-scale prospective or retrospective study of the causes of peri-implant infection has been conducted in Russia or in Moscow. The pathogenesis of peri-implant infection remains unexplored, and methodological approaches to its prevention and treatment have not been developed, making this topic relevant and promising. The project's results will establish the key links in the pathogenesis of peri-implant infection, define the risk spectrum for this complication, identify individual patient characteristics that increase the risk of developing this complication, determine the underlying mechanisms underlying its development, and identify alternative treatment options for these patients. Based on the data obtained, diagnostic algorithms and recommendations will be developed for treatment strategies and preoperative preparation for patients with severe forms of hip and knee osteoarthritis, femoral head fractures, and aseptic necrosis. Guidelines for the antemortem and postmortem diagnosis of peri-implant infection will also be developed. These guidelines will be used by general practitioners, rheumatologists, orthopedic traumatologists, pathologists, rehabilitation physicians, general practitioners, and endocrinologists. The program's implementation and implementation of its results are aimed at reducing the share of peri-implant infection in morbidity and mortality. 2. Objective and Tasks Project Objective: To establish the etiopathogenesis and morphological tissue changes following complications of large joint arthroplasty (PJI, aseptic instability, etc.) in patients of different age groups, assessing their somatic and immune status, calcium mineral metabolism, and its metabolism, and to develop guidelines for preoperative examination.
List of tasks to be addressed within the Project: 1. Develop a clinical study protocol; 2. Recruit a cohort of at least 600 patients for the study to conduct a comprehensive assessment of the patient's baseline status: assessment of mineral metabolism (total calcium, serum magnesium, inorganic phosphorus, 25OH, vitamin D, osteocalcin, BetaCross laps, P1NP bone matrix formation marker, parathyroid hormone); Immune status assessment (Interleukin 10 (IL-10), Interleukin 1 beta (IL-1beta, IL-1b), Interleukin 6 (IL-6), Interleukin 8 (IL-8), Complement Component C4, TNF (Tumor Necrosis Factor alpha, TNFalpha, sachectin), Lymphocyte phenotyping (main subsets panel): CD3, CD4, CD8, CD19, CD16, 56); Microbiological and PCR testing, as well as somatic status (therapist, rheumatologist) and analysis of the results of instrumental examinations (MRI, CT, densitometry, radiography). 3. The study includes a single, less often twice-time examination of each patient from the group of above-mentioned indicators at the preoperative stage. 4. Conducting a study of each patient with complications of osseointegration of the endoprosthesis from the group of above-mentioned indicators at the postoperative stage. 5. Endoprosthetics/revision endoprosthetics of the knee and hip joint. 6. Collection of tissue samples and metal structures (their fragments) from peri-implant areas for an intravital pathological examination of the patient, scanning electron microscopy, sonication, followed by microbiological examination (at least 5 samples) to characterize the microbiota in patients with developed complications.; 7. Evaluation of the obtained results of the correlation between the patient's somatic, immune, and homeostatic (mineral) status and the development of postoperative complications, statistical analysis of the data, and creation of a database.; 8. Implementation of the results of the work into clinical practice at least at the State Budgetary Healthcare Institution "City Clinical Hospital No. 31 named after Academician G.M. Savelyeva"
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 45 years and older
Clinical diagnosis: Idiopathic coxarthrosis stage 3
Clinical diagnosis: Secondary coxarthrosis stage 3 (ANFH, post-traumatic coxarthrosis, rheumatoid arthritis, etc.)
Clinical diagnosis: Idiopathic gonarthrosis stage 3
Disqualifiers
Patients with knee and/or hip joint infection
Patient refusal to participate in the study
Inability to follow up for 3 years
History of psychiatric illness
Trial population
residents of the city of Moscow and the region
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Harris Hip Score
Patients will be surveyed using a specialized scale to stratify the severity of their osteoarthritis and the degree of impairment in their daily activities. The results obtained will be compared with the final results after surgery. Harris Hip Score is 0 to100 scale 90-100: Excellent 80-89: Good 70-79: Fair \<70: Poor result of hip arthroplasty
Concentration of IL-6
A laboratory analysis will be performed to determine the concentration of interleukin 6 in the patients' blood preoperatively. If complications develop after prosthetic replacement, a correlation will be calculated between the concentration of this biomarker in the blood and the incidence of complications.
Oxford hip score
Patients will be surveyed using a specialized scale to stratify the severity of their osteoarthritis and the degree of impairment in their daily activities. The results obtained will be compared with the final results after surgery. Oxford hip score is 0 to 48 scale 0 - 19 Severe 20 - 29 Moderate 30 - 39 mild 40 - 48 Satisfactory result of arthroplasty
Knee Society Score
Patients will be surveyed using a specialized scale to stratify the severity of their osteoarthritis and the degree of impairment in their daily activities. The results will be compared with the final results after surgery. Knee Society Score is 0 to 100 scale This scale does not assign scores to specific joint function. The total score is used to compare results between groups, with the group with the higher mean score indicating a better arthroplasty outcome.
Secondary outcomes
C-reactive protein concentration
In the event of periprosthetic infection or aseptic loosening, a laboratory analysis of the concentration of this biomarker will be performed in order to determine the correlation between its concentration and the frequency and outcome of complications.
study of microflora culture from a liquid medium after sonication
After removal of implants, if periprosthetic complications develop, they will be sonicated to isolate flora as plankton into the liquid medium and to test it for the presence of the infectious agent and its sensitivity to antibiotics.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.