NCT05278520

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2023Dec 2028

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

5.9 years

First QC Date

March 3, 2022

Last Update Submit

August 18, 2025

Conditions

Keywords

Single-cell RNA sequencingSpatial transcriptomicsOsteoarthritisRheumatoid arthritisSpatial proteomics

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Starting during the last quarter of 2024, ending by the last quarter of 2028.

Secondary Outcomes (2)

  • Biomarkers for OA

    Starting during the second half of 2026, ending by the last quarter of 2028.

  • OA endotypes

    Starting during the first half of 2025, ending by the second half of 2027.

Study Arms (3)

OA cases

Fifty adult patients who have hip osteoarthritis.

Procedure: Total hip arthroplasty

RA cases

Forty adult patients who have rheumatoid arthritis in the hip joint.

Procedure: Total hip arthroplasty

Non-arthritic controls

Twenty adult patients who go through trauma-based emergency total hip arthroplasty and do not have arthritis.

Procedure: Total hip arthroplasty

Interventions

Hip joint replacement surgery. Elective for RA and OA cases.

Non-arthritic controlsOA casesRA cases

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • \----

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

PET-centre, University of Turku

Turku, Southwest Finland, Finland

ACTIVE NOT RECRUITING

Turku Bioscience, University of Turku

Turku, Southwest Finland, Finland

ACTIVE NOT RECRUITING

Turku University Hospital

Turku, Southwest Finland, Finland

RECRUITING

Helsinki University Hospital

Espoo, Uusimaa, Finland

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Hip joint synovial tissues and bone, peripheral blood mononuclear cells, serum, plasma, and whole blood.

MeSH Terms

Conditions

Osteoarthritis, HipArthritis, RheumatoidOsteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Lea Mikkola, PhD

    Turku Bioscience, University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Mikkola, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

January 11, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations