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RecruitingNCT07347821Updated Jan 16, 2026

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

An observational study in Total Hip Arthroplasty (THA), Total Knee Arthroplasty (TKA) and Hip Osteoarthritis, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Medical University of Warsaw · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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?

02

Conditions studied

  • Total Hip Arthroplasty (THA)
  • Total Knee Arthroplasty (TKA)
  • Hip Osteoarthritis
  • Knee Osteoarthristis

Keywords

  • Total Knee Replacement
  • Total Hip Replacement
  • Trace Elements
  • Osteoarthritis
  • Cytokines
  • Oxidative Stress
03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients undergoing primary total knee arthroplasty
  • patients undergoing primary total hip arthroplasty
06

What researchers measure

Primary outcomes

  1. 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).

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  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).

    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).

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

07

Study locations

1 of 1 sites recruiting
  • Szpital Powiatowy im. M. Skłodowskiej-Curie
    Ostrów Mazowiecka, Masovian Voivodeship 07-300, Poland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07347821
Lead sponsor
Medical University of Warsaw
Responsible party
Sponsor
First posted
Jan 16, 2026
Start date
Nov 22, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 16, 2026

Study contacts

Artur Stolarczyk, Professor
Contact
artur.stolarczyk@wum.edu.pl
+48224735218
View the source record on ClinicalTrials.gov ↗

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