Osteoarthritis, HipOASEQNCT05278520
Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis
An observational study of Osteoarthritis, Hip and Rheumatoid Arthritis, run by University of Turku at 4 sites in Finland.
Trial summary
The purpose of this study is to cast light on the highly complex etiology and cellular landscape of hip osteoarthritis by utilising single-cell and spatial omics. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip, Rheumatoid Arthritis
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 4 sitesFinland
- Study dates
- 11 Jan 2023to 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 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients of the HUS (Joint Authority of the Helsinki and Uusimaa Hospital District) Center of Arthroplasty and the Orto Surgical Hospital of Turku University.
Who may be able to join
- Cases: Adult patients with osteoarthritis in the hip joint and who are going through an elective total hip arthroplasty.
- Controls: Non-arthritis adult patients who are going through a trauma-based emergency total hip arthroplasty.
- ----
- Adult patients with rheumatoid arthritis in the hip joint and who are going through an elective total hip arthroplasty.
- ----
Who cannot join
- The body mass index must be below 35
- Age < 18 or > 74
- The OA patients may not have diabetes, rheumatoid arthritis (RA), or metabolic syndrome.
- For the Rheumatoid sub-study, the exclusion criteria are the same as above except for the RA.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland4 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Espoo, Uusimaa
Anna Vasara, MD, PhD, anna.vasara@hus.fi
Anna Vasara, MD, PhD
- Active, not recruiting
PET-centre, University of Turku
Turku, Southwest Finland
- Active, not recruiting
Turku Bioscience, University of Turku
Turku, Southwest Finland
- Recruiting
Turku University Hospital
Turku, Southwest Finland
Pjotr Sarantsin, MD, Pjotr.Sarantsin@tyks.fi
Pjotr Sarantsin, MD
About this study
Official title: Studies on the Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis
The purpose of this study is to cast light on the highly complex etiology and cellular landscape of hip osteoarthritis by utilising single-cell and spatial omics.
Read the detailed description
The specific objectives of this project are:
- Using the latest single-cell RNA sequencing (scRNAseq) techniques the investigators aim to A) characterize what kind of cell populations are found in different synovial tissues and blood derived samples of OA patients, B) determine how the cell composition differs between arthritic and corresponding non-arthritic tissues, C) map the transcriptional and regulatory landscape of the cells mentioned in A and B focusing on the inflammatory responses, D) determine what are the key molecular pathways activated in OA.
- To determine if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.
- To map the whole transcriptome and proteome of OA and non-arthritic control tissue while keeping the morphological context with spatial omics technologies.
- Further differentiation and identification of OA endotypes utilizing the single-cell and spatial omics data.
The project includes a Rheumatoid sub-study where the main objective is to compare arthritic tissue and peripheral blood constituents between OA and rheumatoid arthritis patients to explore the differences in the disease mechanisms.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis
- Being tested
- Total hip arthroplasty
- Keywords
- Single-cell RNA sequencing, Spatial transcriptomics, Osteoarthritis, Rheumatoid arthritis, Spatial proteomics
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
Hip joint replacement surgery. Elective for RA and OA cases.
| Study group | Role | What they receive |
|---|---|---|
| OA cases | Fifty adult patients who have hip osteoarthritis. Receives: Procedure: Total hip arthroplasty | |
| RA cases | Forty adult patients who have rheumatoid arthritis in the hip joint. Receives: Procedure: Total hip arthroplasty | |
| Non-arthritic controls | Twenty adult patients who go through trauma-based emergency total hip arthroplasty and do not have arthritis. Receives: Procedure: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of cell populations in OA
Characterization of cell populations found in different synovial tissues and blood derived samples of OA patients utilising single-cell RNA sequencing solutions.
Measured: Starting during the first quarter of 2025, ending by the last quarter of 2026.
Comparison of cell populations between OA cases and controls
The investigators will determine how the cell composition differs between arthritic and corresponding non-arthritic tissues utilising single-cell RNA sequencing solutions.
Measured: Starting during the first quarter of 2025, ending by the last quarter of 2026.
Cellular landscape in OA
The investigators will map the transcriptional, regulatory and protein landscape of OA at single-cell and tissue (spatial) level.
Measured: Starting during the last quarter of 2024, ending by the last quarter of 2026.
Key molecular pathways of OA
The investigators will determine what are the key molecular pathways activated in OA.
Measured: Starting during the last quarter of 2025, ending by the last quarter of 2027.
Comparison of disease mechanisms between RA and OA
In the Rheumatoid sub-study the investigators will explore the differences in the disease mechanisms between OA and RA by comparing synovial tissues and peripheral blood sample constituents.
Measured: Starting during the last quarter of 2024, ending by the last quarter of 2028.
Secondary outcomes (2)
Biomarkers for OA
The investigators will investigate if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.
Measured: Starting during the second half of 2026, ending by the last quarter of 2028.
OA endotypes
The investigators aim to identify and further differentiate OA endotypes by utilizing the single-cell and spatial data.
Measured: Starting during the first half of 2025, ending by the second half of 2027.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start11 Jan 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Hospital District of Helsinki and Uusimaa
- Responsible party
- Principal investigator, Lea Mikkola, University of Turku
- Investigators
- Lea Mikkola, PhD, Principal investigator, Turku Bioscience, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278520
- Sponsor's protocol ID
- 2022OASEQ
- Acronym
- OASEQ
- Status last verified
- Aug 2025
- First submitted
- 3 Mar 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rydgren E, Kotilainen SK, Piipponen M, Lönnberg T, Mikkola L. COMPARISON OF TWO HIGH-RESOLUTION SPATIAL TRANSCRIPTOMICS TECHNOLOGIES TO STUDY SYNOVIAL IMMUNE INFILTRATION IN OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS Osteoarthritis and Cartilage, Volume 33, Issue 6, 2025, page 816. https://doi.org/10.1016/j.joca.2025.03.079
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT05278520
- Acronym / sponsor ID
- OASEQ / 2022OASEQ
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis
- Keywords
- Single-cell RNA sequencing, Spatial transcriptomics, Osteoarthritis, Rheumatoid arthritis, Spatial proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Turku University Hospital, Hospital District of Helsinki and Uusimaa
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Mar 2022 (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 purpose of this study is to cast light on the highly complex etiology and cellular landscape of hip osteoarthritis by utilising single-cell and spatial omics.
Detailed description
The specific objectives of this project are:
- Using the latest single-cell RNA sequencing (scRNAseq) techniques the investigators aim to A) characterize what kind of cell populations are found in different synovial tissues and blood derived samples of OA patients, B) determine how the cell composition differs between arthritic and corresponding non-arthritic tissues, C) map the transcriptional and regulatory landscape of the cells mentioned in A and B focusing on the inflammatory responses, D) determine what are the key molecular pathways activated in OA.
- To determine if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.
- To map the whole transcriptome and proteome of OA and non-arthritic control tissue while keeping the morphological context with spatial omics technologies.
- Further differentiation and identification of OA endotypes utilizing the single-cell and spatial omics data.
The project includes a Rheumatoid sub-study where the main objective is to compare arthritic tissue and peripheral blood constituents between OA and rheumatoid arthritis patients to explore the differences in the disease mechanisms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OA cases | – | Procedure: Total hip arthroplastyFifty adult patients who have hip osteoarthritis. |
| RA cases | – | Procedure: Total hip arthroplastyForty adult patients who have rheumatoid arthritis in the hip joint. |
| Non-arthritic controls | – | Procedure: Total hip arthroplastyTwenty adult patients who go through trauma-based emergency total hip arthroplasty and do not have arthritis. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of the HUS (Joint Authority of the Helsinki and Uusimaa Hospital District) Center of Arthroplasty and the Orto Surgical Hospital of Turku University.
Key inclusion criteria (5 listed)
- Cases: Adult patients with osteoarthritis in the hip joint and who are going through an elective total hip arthroplasty.
- Controls: Non-arthritis adult patients who are going through a trauma-based emergency total hip arthroplasty.
- ----
- Adult patients with rheumatoid arthritis in the hip joint and who are going through an elective total hip arthroplasty.
- ----
Key exclusion criteria (4 listed)
- The body mass index must be below 35
- Age < 18 or > 74
- The OA patients may not have diabetes, rheumatoid arthritis (RA), or metabolic syndrome.
- For the Rheumatoid sub-study, the exclusion criteria are the same as above except for the RA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip arthroplastyHip joint replacement surgery. Elective for RA and OA cases. | Procedure or surgery | Non-arthritic controls, OA cases, RA cases |
Primary outcome
Characterization of cell populations in OA
Time frame: Starting during the first quarter of 2025, ending by the last quarter of 2026.
Characterization of cell populations found in different synovial tissues and blood derived samples of OA patients utilising single-cell RNA sequencing solutions.
Comparison of cell populations between OA cases and controls
Time frame: Starting during the first quarter of 2025, ending by the last quarter of 2026.
The investigators will determine how the cell composition differs between arthritic and corresponding non-arthritic tissues utilising single-cell RNA sequencing solutions.
Cellular landscape in OA
Time frame: Starting during the last quarter of 2024, ending by the last quarter of 2026.
The investigators will map the transcriptional, regulatory and protein landscape of OA at single-cell and tissue (spatial) level.
Key molecular pathways of OA
Time frame: Starting during the last quarter of 2025, ending by the last quarter of 2027.
The investigators will determine what are the key molecular pathways activated in OA.
Comparison of disease mechanisms between RA and OA
Time frame: Starting during the last quarter of 2024, ending by the last quarter of 2028.
In the Rheumatoid sub-study the investigators will explore the differences in the disease mechanisms between OA and RA by comparing synovial tissues and peripheral blood sample constituents.
2 secondary outcomes
Biomarkers for OA
Time frame: Starting during the second half of 2026, ending by the last quarter of 2028.
OA endotypes
Time frame: Starting during the first half of 2025, ending by the second half of 2027.
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 24 Aug 2025.
- Results publicationRydgren E, Kotilainen SK, Piipponen M, Lönnberg T, Mikkola L. COMPARISON OF TWO HIGH-RESOLUTION SPATIAL TRANSCRIPTOMICS TECHNOLOGIES TO STUDY SYNOVIAL IMMUNE INFILTRATION IN OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS Osteoarthritis and Cartilage, Volume 33, Issue 6, 2025, page 816. https://doi.org/10.1016/j.joca.2025.03.079
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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.
Lea Mikkola, PhD principal investigator
Turku Bioscience, University of Turku
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Rheumatoid Arthritis, run by University of Turku at 4 sites in Finland.
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 4 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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 Lea Mikkola, PhD (+358404143300, limikk@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of cell populations in OA (time frame: Starting during the first quarter of 2025, ending by the last quarter of 2026.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278520, which also lists 1 linked publication.
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 24 Aug 2025.