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Recruiting NCT07347821

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Total Hip Arthroplasty (THA), Total Knee Arthroplasty (TKA), Hip Osteoarthritis, Knee Osteoarthristis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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?

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • 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)]
  • Trace element concentration in periarticular tissues (e.g., Zn, Cu, Fe). [Time frame: 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). [Time frame: Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Poland · 1 center
  • Szpital Powiatowy im. M. Skłodowskiej-Curie — Ostrów Mazowiecka

Identifiers

NCT: NCT07347821 · KB/129/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗