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NCT Number: NCT07347821

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?

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Key information

Conditions

Total Hip Arthroplasty (THA) Arthritis Hip Osteoarthritis Joint Diseases Knee Osteoarthristis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases Total Knee Arthroplasty (TKA)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Szpital Powiatowy im. M. Skłodowskiej-Curie

Ostrów Mazowiecka, Masovian Voivodeship, 07-300, Poland

Location status: Recruiting

Location contact

Artur Stolarczyk, Professor

CONTACT

[email protected]

+48224735218

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Enzymatic activity of selected proteolytic enzymes in periarticular tissue homogenate (e.g., metalloproteinases and selected serine/cysteine proteases).

    Time frame: Perioperative/Periprocedural (during primary THA/TKA; index hospitalization)

    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).

Secondary outcomes

  1. Protein concentration of selected inflammatory markers in blood (e.g., TNF-α, IL 17α).

    Time frame: Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)

    Protein concentrations measured by enzyme immunoassays (EIA/ELISA). Each protein will be reported separately as pg/mL.

  2. Trace element concentration in periarticular tissues (e.g., Zn, Cu, Fe).

    Time frame: Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)

    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.

  3. 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).

    Time frame: Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Artur Stolarczyk, Professor

CONTACT

[email protected]

+48224735218

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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