Total Hip Arthroplasty (THA)NCT07347821
Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty
An observational study of Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA), run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA), Total Knee Arthroplasty (TKA), Hip Osteoarthritis
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 22 Nov 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Szpital Powiatowy im. M. Skłodowskiej-Curie
Ostrów Mazowiecka, Masovian Voivodeship, 07-300
Artur Stolarczyk, Professor, +48224735218, artur.stolarczyk@wum.edu.pl
About this study
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
- 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
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing primary total knee arthroplasty | Not described | |
| patients undergoing primary total hip arthroplasty | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Protein concentrations measured by enzyme immunoassays (EIA/ELISA). Each protein will be reported separately as pg/mL.
Measured: Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)
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.
Measured: 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).
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).
Measured: Perioperative/Periprocedural (day of surgery; index hospitalization for primary THA/TKA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start22 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347821
- Sponsor's protocol ID
- KB/129/2025
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty
- ClinicalTrials.gov ID
- NCT07347821
- Acronym / sponsor ID
- KB/129/2025
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients undergoing primary total knee arthroplasty | – | – |
| patients undergoing primary total hip arthroplasty | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for Total Hip Arthroplasty (THA)
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Enrolling by invitationPhase 2
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Total Hip Arthroplasty
Enrolling by invitationPhase 3
A Clinical Trial Evaluating the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty in China
Pain After Abdominal Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA), run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Artur Stolarczyk, Professor (+48224735218, artur.stolarczyk@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.