Analysis of the Etiopathogenesis of Postoperative Complications in Orthopedic Patients Using Knee and Hip Arthroplasty as an Example

NCT07813832 | Recruiting

• 1 other identifier: 37
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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"

Conditions

Periprosthetic Joint Infection (PJI); Periprosthetic Knee Infection; Periprosthetic Hip Infection; Diagnostic; Prediction

Keywords

Periprosthetic joint infection (PJI); Biomarkers; Periprosthetic knee infection; periprosthetic hip infection

Outcome Measures

Primary Outcomes (6)

• 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

  Baseline

• 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.

  Baseline

• 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

  Baseline

• 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.

  baseline

• Concentraion of HbA1c

  A laboratory analysis will be performed to determine the concentration of HbA1c 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.

  baseline

• MRI of the knee and hip joint

  An instrumental diagnosis of the joints will be performed to determine the aseptic process or the presence of perifocal inflammation of the paraacarticular tissues

  baseline

Secondary Outcomes (2)

• C-reactive protein concentration

  perioperatively

• study of microflora culture from a liquid medium after sonication

  immediately after the surgery

Study Arms (2)

Primary THA and TKA

Patients undergoing primary hip or knee replacement

Revision THA and TKA

Patients undergoing revision hip or knee replacement

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

residents of the city of Moscow and the region

You may qualify if:

• 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
• Clinical diagnosis: Secondary gonarthrosis stage 3 (aseptic necrosis, post-traumatic gonarthrosis, rheumatoid arthritis, etc.)

You may not qualify if:

• 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
• Decompensated somatic illness

Sponsors & Collaborators

• People's Friendship University of Russia: lead

Study Sites (1)

City clinical Hospital №31

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Asadula R. Abasov

CONTACT

+7 930 416 7411; asadula_abasov@mail.ru

Ivan A. Dmitrov, PhD

CONTACT

dr.dmitrov@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., orthopedic surgeon, postgraduate student of the Department of Traumatology and Orthopedics at People's Friendship University of Russia

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: September 10, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): May 20, 2029
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

RU (1)