Rare metals and immune markers in hip and knee tissue from patients having joint replacement

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

This project will see if levels of rare metals, trace elements, and certain immune markers are low in the joint tissue and blood of adults having hip or knee replacement for osteoarthritis.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical University of Warsaw (other)
• Locations: 1 site (Ostrów Mazowiecka, Masovian Voivodeship)
• Trial ID: NCT07347821 on ClinicalTrials.gov

What this trial studies

This is an observational, single-center project that collects tissue and blood from adults undergoing primary elective total hip or knee arthroplasty for osteoarthritis. Laboratory analyses will measure the content of selected rare metals and trace elements in joint tissue and serum, together with chosen immunological parameters such as cytokine levels. Patients with genetic connective tissue or metabolic disorders, autoimmune disease, prior joint-altering surgery, revision arthroplasty, or traumatic joint injury are excluded to reduce confounding. Findings will be compared across the collected samples to identify potential disturbances in metal content or immune markers that could inform future interventions.

Who should consider this trial

Good fit: Adults aged 18 or older with hip or knee osteoarthritis who are scheduled for primary total hip or knee arthroplasty and can provide a complete set of good-quality tissue samples are ideal candidates.

Not a fit: Patients with autoimmune disease, genetic connective tissue or metabolic disorders, prior surgeries that altered the joint, revision arthroplasty, traumatic joint injury, or who do not consent are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could point to metal deficiencies or immune alterations that might be corrected by targeted supplementation or immune-focused therapies to improve osteoarthritis care.

How similar studies have performed: Previous research has reported altered trace elements and cytokine patterns in osteoarthritis but results are inconsistent, so this combined tissue-and-serum approach is relatively novel and exploratory.

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.

Where this trial is running

Ostrów Mazowiecka, Masovian Voivodeship

• Szpital Powiatowy im. M. Skłodowskiej-Curie — Ostrów Mazowiecka, Masovian Voivodeship, Poland (RECRUITING)

Study contacts

• Study coordinator: Artur Stolarczyk, Professor

Conditions: Total Hip Arthroplasty, Total Knee Arthroplasty, Hip Osteoarthritis, Knee Osteoarthristis, Total Knee Replacement, Total Hip Replacement, Trace Elements, Osteoarthritis