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

September 6, 2026 updated by: Asadula Raufovich Abasov, People's Friendship University of Russia

Analysis of the Etiopathogenesis of Postoperative Complications in the Orthopedic Profile of Moscow Using the Example of Knee and Hip Arthroplasty and the Development of an Algorithm for the Diagnosis and Prevention of These Complications

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"

Study Overview

Status

Recruiting

Conditions

Detailed Description

1. Relevance and Rationale A significant number of conditions encountered by orthopedic traumatologists have a progressive course, and the question of reconstructive surgery using various types of implants invariably arises in the terminal stages. The scientific novelty of this study lies in the large-scale prospective study of patients before and after endoprosthetic replacement with endosseous implants. This study will include an assessment of mineral homeostasis, somatic status, and immune status. It will also provide a morphological characterization of bone tissue in the implantation area and, in patients with periimplantitis, an assessment of the microbiota around the implants. The clinical problem addressed by this project-assessing the prevalence of complications after large joint replacement in the Russian Federation-has several limitations, primarily related to the collection and analysis of statistical data. However, according to a 2019 epidemiological study, In 2018, 6,606 cases of implant-associated infection after knee or hip arthroplasty were registered in the country, accounting for 2.91% of primary surgeries [Sereda A.P. et al. Epidemiology of hip and knee arthroplasty and periprosthetic infection in the Russian Federation // Traumatology and Orthopedics of Russia. Vreden Russian Research Institute of Traumatology and Orthopedics, 2021. Vol. 27, No. 3. P. 84-93.]. Description of the problem being solved

  1. An increase in the number of patients with peri-implant infection, aseptic instability, periprosthetic fractures, the need for re-hospitalization and surgeries, an unpredictable outcome of retreatment, excess mortality, and a high economic burden. 2. The problem affects a wide range of age groups of patients who have undergone knee and hip arthroplasty, as well as traumatologists and orthopedists working in the trauma and orthopedic centers of the Moscow Health Department. 3. A progressive increase in the incidence of peri-implant infection, aseptic instability, periprosthetic fractures, an increased financial burden on Moscow healthcare, an increase in mortality associated with this disease, and an increase in disability.

    Due to the widespread development of high-tech medical care in traumatology and orthopedics, provided to patients with severe forms of osteoarthritis of the hip and knee joints and aseptic necrosis, and the increase in the number of knee and hip arthroplasties, there is a proportional increase in serious complications after arthroplasty, and the most formidable of these

    and economically costly is the development of Peri-implant infection. Currently, the incidence of peri-implant infection is approaching epidemic proportions. It is worth noting that peri-implant infection is not always associated with poor surgical technique or poor quality 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 has not been fully elucidated, and methodological approaches to prevention and treatment for this group of patients have not been developed, making this topic relevant and promising. The project's results will establish the key pathogenesis of peri-implant infection, determine the risk spectrum for this complication, identify individual patient characteristics that increase the risk of developing this complication, determine the underlying mechanisms of this complication, and identify alternative management options for these patients. Based on the data obtained, diagnostic algorithms and recommendations for treatment strategies and preoperative preparation for patients with severe forms of hip and knee osteoarthritis, femoral head fractures, and aseptic necrosis will be developed. 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 contribution of peri-implant infection to morbidity and mortality. 2. Objectives and Tasks The Project's Objective is to establish the etiopathogenesis and morphological changes in tissues following complications of large joint replacement (PJI, aseptic instability, etc.) in patients of different age groups, assessing somatic and immune status, calcium mineral balance, and its metabolism, and to develop guidelines for preoperative examination.

  2. Recruitment of a cohort of patients within the study of at least 600 people for 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); assessment of the immune status (Interleukin 10 (IL-10, Interleukin 10, IL-10), Interleukin 1 beta (IL-1beta, IL-1b, Interleukin 1 beta, IL-1b), Interleukin 6 (IL-6, Interleukin 6, IL-6), Interleukin 8 (IL-8, Interleukin 8, IL-8), C4 Component of the complement system (Complement Component C4), TNF (Tumor necrosis factor, Tumor necrosis factor alpha, TNFalpha, sachectin), Lymphocyte phenotyping (main subsets panel): CD3, CD4, CD8, CD19, CD16, 56); microbiological research and PCR research, as well as somatic status (therapist, rheumatologist) and analysis of the results of the instrumental research methods (MRI, CT, densitometry, radiography).; 3. The study includes a single, less often double study in each patient from the group of the above-mentioned indicators at the preoperative stage.; 4. Conducting a study in each patient with complications of osseointegration of the endoprosthesis from the group of the 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 with subsequent microbiological examination (at least 5 samples) to form a characteristic of the microbiota in patients with developed complications.; 7. Evaluation of the obtained results of the correlation dependence of the patient's somatic, immune, and homeostatic (mineral) status on the development of postoperative complications, statistical data analysis, and database creation. 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 of the Moscow Health Department." 9. Characterize pathomorphological and immunohistochemical changes, including an assessment of local immunity (CD3, CD4, CD8, CD20, CD56, CD68) in the peri-implant area.

Study Design Materials and Methods Sample size of patients participating in the study: 750 patients Rationale for sample size calculation Power calculations were performed for a minimum number of patients of 400-450

  1. Power Formula For a t-test for the difference between two independent means: Power = 1 - β = P(T>t_{crit} | H_{1} ) where T is a non-central t-distribution with degrees of freedom: df = n₁ + n₂ - 2 non-centrality parameter: δ = d ⋅ √(n₁ n₂ / (n₁ + n₂)) t_{crit} = t_{1-α/2, df} (two-tailed critical t) Total: Power = 1 -F_{nc}(t_{crit}; df, δ) F_{nc} is the distribution function of non-central t.

  2. Substitute the numbers n₁ = n₂ = 200, df = 398α = 0.05 → t_{crit} ≈ 1.968 Cohen's d = 0.3 δ = 0.3 × √(200 200 / 400) = 0.3 × √100 = 3.0

    Calculate the probability:

    Power = 1 -F_{nc}(1.968; 398, 3.0) ≈ 0.70 Answer: power ≈ 70%.

  3. Cohen's d d = (μ₁ - μ₂) / σ μ₁, μ₂ - means of two groups σ - "overall" standard deviation (pooled SD) Interpretation (Cohen, 1988): 0.2 - small effect 0.5 - medium effect 0.8 - large effect Description of cohorts/groups of patients Cohort #1: Patients with hip pathology who are indicated for hip arthroplasty Size of group/cohort #1, people: 300

Inclusion criteria for group/cohort #1:

Patients 45 years and older Idiopathic coxarthrosis Stage 3 Secondary coxarthrosis stage 3 (ANFH, post-traumatic coxarthrosis, rheumatoid arthritis, etc.)

Exclusion criteria for Group/Cohort No. 1:

Patients with infection of the hip joint; Patient's refusal to participate in the study; Inability to follow up the patient for 3 years; History of psychiatric illness; Somatic illnesses in the decompensation stage Group/Cohort #2 Size, Persons: 300

The indicators that will be assessed in the study of cohort/group No. 1 before the primary operation and before surgery in case of revision intervention are:

Beta-Cross Laps

Chemical Blood Count

Bone Matrix Formation Marker P1NP

Parathyroid Hormone Wound Microbiota Culture

Total Calcium

25OH Vitamin D

Serum Magnesium

Interleukin 10

Interleukin 1 Beta Interleukin 6 Interleukin 8

Tumor necrosis factor Phagocytic activity of leukocytes

Detection of herpes viruses by PCR Immunohistochemistry of six (6) types of antibodies (CD3, CD4, CD8, CD20, CD56, CD68) Lymphocyte phenotyping (major subsets) - CD3, CD4, CD8, CD19, CD16, CD56

Densitometry

MRI of the hip joint

CT scan of the hip joint

Pelvic X-ray Pathological examination of a femoral head bone section Pathological examination of intra-articular tissues

X-ray of the hip joint Sonication of removed implants and subsequent microbiological examination Physician's report Sampling of throat and nasal discharge PCR testing for infectious agents (virals, bacteria, fungi) with assessment of the microbiota in the peri-implant area EGD

Inorganic phosphorus

Total protein

Albumin ALT AST

Creatinine

Urea

Uric acid

Glucose

Glycated hemoglobin

Total bilirubin

Direct bilirubin

Gamma-GT

Blood Fe

Cholesterol

Triglycerides

Potassium

Sodium

Chloride

C-reactive protein

ESR

Rheumatoid factor

APTT

INR

Inclusion Criteria for Group/Cohort #2:

Patients 45 years and older Stage 3 idiopathic gonarthrosis Stage 3 secondary gonarthrosis (aseptic necrosis, post-traumatic gonarthrosis, rheumatoid arthritis, etc.)

Exclusion Criteria for Group/Cohort #2:

Patients with knee joint infection Patient refusal to participate in the study Inability to follow up for 3 years History of psychiatric illness Somatic illness in the stage of decompensation Justification for the absence of a control group

The indicators that will be assessed in the study of cohort/group No. 2 before the primary operation and before surgery in case of revision intervention are:

Beta-Cross Laps

Chemical Blood Count

Bone Matrix Formation Marker P1NP

Parathyroid Hormone Wound Microbiota Culture

Total Calcium

25OH Vitamin D

Serum Magnesium

Interleukin 10

Interleukin 1 Beta Interleukin 6 Interleukin 8

Tumor necrosis factor Phagocytic activity of leukocytes

Detection of herpes viruses by PCR Immunohistochemistry of six (6) types of antibodies (CD3, CD4, CD8, CD20, CD56, CD68) Lymphocyte phenotyping (major subsets) - CD3, CD4, CD8, CD19, CD16, CD56

Densitometry

MRI of the hip joint

CT scan of the hip joint

Pelvic X-ray Pathological examination of a femoral head bone section Pathological examination of intra-articular tissues

X-ray of the hip joint Sonication of removed implants and subsequent microbiological examination Physician's report Sampling of throat and nasal discharge PCR testing for infectious agents (virals, bacteria, fungi) with assessment of the microbiota in the peri-implant area EGD

Inorganic phosphorus

Total protein

Albumin ALT AST

Creatinine

Urea

Uric acid

Glucose

Glycated hemoglobin

Total bilirubin

Direct bilirubin

Gamma-GT

Blood Fe

Cholesterol

Triglycerides

Potassium

Sodium

Chloride

C-reactive protein

ESR

Rheumatoid factor

APTT

INR

This scientific work is a cohort study, which does not imply a control group. Whether patients participating in the study will sign written informed consent: Yes Whether approval from the ethics committee for conducting research with patients will be obtained: Yes Name of the ethics committee: Ethics Committee of the State Budgetary Healthcare Institution City Clinical Hospital No. 31 named after Academician G.M. Savelyeva, Department of Health of the City of Moscow Conclusion Reduction in the development of postoperative complications, with a special emphasis on preventing periprosthetic infection. This serious complication not only causes significant suffering to the patient but also requires long-term, multi-stage, and expensive treatment, including revision surgery. To Improving the quality and standardization of medical care in primary arthroplasty by implementing proven clinical protocols for preoperative diagnosis and patient selection. A key component is an individualized approach that takes into account the patient's comorbidities, minimizing the risk of perioperative negative consequences. A logical continuation of this work is reducing the number of readmissions due to complications such as instability of endoprosthesis components and wound infection.

Achieving this goal directly depends on the effectiveness of the measures taken at the previous stages, as well as on establishing a high-quality preoperative diagnostic system. An integral and extremely significant result of implementing all of the above measures is a significant reduction in the economic burden associated with the treatment of these postoperative complications. Each complication entails direct costs for repeat surgeries, expensive antibiotics, prolonged hospital stays and subsequent rehabilitation, as well as indirect losses due to prolonged patient disability. Thus, investments in prevention, quality improvement, and standardization of medical care not only improve clinical outcomes and patient satisfaction, but also demonstrate high cost-effectiveness, reducing the burden on the healthcare system and optimizing resource allocation.

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

residents of the city of Moscow and the region

Description

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Primary THA and TKA
Patients undergoing primary hip or knee replacement
Revision THA and TKA
Patients undergoing revision hip or knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: Baseline

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
Time Frame: Baseline
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
Time Frame: Baseline

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
Time Frame: baseline

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
Time Frame: baseline
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
Time Frame: baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein concentration
Time Frame: perioperatively
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.
perioperatively
study of microflora culture from a liquid medium after sonication
Time Frame: immediately after the surgery
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.
immediately after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

People's Friendship University of Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

May 20, 2029

Study Registration Dates

First Submitted

August 22, 2026

First Submitted That Met QC Criteria

September 6, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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