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

NCT07347821 | Recruiting

• 1 other identifier: KB/129/2025
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

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

Keywords

Total Knee Replacement; Total Hip Replacement; Trace Elements; Osteoarthritis; Cytokines; Oxidative Stress

Outcome Measures

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).

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

Secondary Outcomes (3)

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

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

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

  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).

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

Study Arms (2)

patients undergoing primary total knee arthroplasty

patients undergoing primary total hip arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Szpital Powiatowy im. M. Skłodowskiej-Curie

Ostrów Mazowiecka, Masovian Voivodeship, 07-300, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Artur Stolarczyk, Professor

CONTACT

+48224735218; artur.stolarczyk@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 16, 2026
• Study Start: November 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-10

Locations

PL (1)