Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty

The aim of this observational study is to determine content of rare metals and other elements, along with the levels of selected immunological parameters, in the tissue of the hip or knee joint in the course of degenerative diseases. Determining potential disturbances in the levels or functions of these parameters may in the future contribute to improving treatment - for example, through supplementation of deficient metals or modulation at the immunological level. The main question it aims to answer is:

Are selected rare metals, trace elements and other selected immunological parameters lowered in the tissue of the hip or knee joint as well as in serum in the course of osteoarthritis?

Study Overview

• Status: Recruiting
• Conditions: Hip Osteoarthritis; Total Knee Arthroplasty (TKA); Knee Osteoarthristis; Total Hip Arthroplasty (THA)

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Artur Stolarczyk, Professor; Phone Number: +48224735218; Email: artur.stolarczyk@wum.edu.pl

Study Locations

• Poland
  • Masovian Voivodeship
    • Ostrów Mazowiecka, Masovian Voivodeship, Poland, 07-300
      • Recruiting
      • Szpital Powiatowy im. M. Skłodowskiej-Curie
      • Contact: Artur Stolarczyk, Professor; Phone Number: +48224735218; Email: artur.stolarczyk@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary THA or TKA at the trauma and orthopedics department of the hospital in Ostrów Mazowiecka, as well as at the trauma and orthopedics department in Międzylesie Specialist Hospital in Poland.

Description

Inclusion Criteria:

• 18 years old and more
• patient qualified for primary TKA or primary THA
• patient diagnosed with hip or knee osteoarthritis
• a complete set of tissues of good quality and volume is available
• does not meet the exclusion criteria.

Exclusion Criteria:

• lack of written consent to participate in the study or surgery
• any private or professional relationship with the Investigators
• genetic connective tissue diseases (e.g., Ehlers-Danlos syndrome and others)
• genetic metabolic diseases (e.g., gout and others)
• genetic diseases affecting the anatomy of the operated joint (e.g., dysplasia and others)
• previous surgeries altering the anatomy of the examined joint (e.g., periacetabular osteotomy, unicompartmental endoprosthesis, and others)
• patients undergoing revision after THA/TKA
• autoimmune diseases in the patient's medical history
• traumatic injury to the hip or knee joint
• previous participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients undergoing primary total knee arthroplasty
patients undergoing primary total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enzymatic activity of selected proteolytic enzymes in periarticular tissue homogenate (e.g., metalloproteinases and selected serine/cysteine proteases).	Enzymatic activity assessed using biochemical/spectrofluorometric methods and normalized to total protein. Each enzyme will be reported separately. Data is planned to be reported as activity units per mg protein (e.g. U/mg protein).	Perioperative/Periprocedural (during primary THA/TKA; index hospitalization)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein concentration of selected inflammatory markers in blood (e.g., TNF-α, IL 17α).	Protein concentrations measured by enzyme immunoassays (EIA/ELISA). Each protein will be reported separately as pg/mL.	Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)
Trace element concentration in periarticular tissues (e.g., Zn, Cu, Fe).	Trace element content measured by Inductively Coupled Plasma - Mass Spectrometry (ICP-MS). Each element will be reported separately. The units for serum measurements is µg/L, and for other tissue is mg/kg dry weight.	Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)
Relative mRNA expression of selected inflammatory and bone metabolism markers in periarticular tissue (e.g. TNF-α, RANK, RANKL, BMP-12, IL-17α, IL-17αR).	Relative mRNA expression measured by RT-qPCR and reported as fold change (e.g., 2^-ΔΔCt). Each gene will be reported separately (no aggregation into a single score).	Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Osteoarthritis; Oxidative Stress; Cytokines; Total Knee Replacement; Trace Elements; Total Hip Replacement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: KB/129/2025