Bone Erosions in Rheumatoid Arthritis - Characterization Evaluated by Imaging and Histology

NCT ID: NCT04645381

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2035-11-30

Brief Summary

The aim of this study is to describe macro- and micro anatomical structures, including investigating vessels running in osseous pores in finger joints from participants with rheumatoid arthritis (RA) using histology and different imaging modalities. The perspectives are to increase understanding of the macro- and micro anatomic basis for bone erosions in RA, and possibly to provide new insights to the monitoring of patients with RA.

Detailed Description

This study is a descriptive, cross-sectional pilot study. The trial subjects will have their hands imaged by conventional radiography. The 2nd and 3rd digit metacarpophalangeal (MCP) joint will be scanned by high-resolution peripheral quantitative computed tomography (HR-pQCT). Patients with RA (n = 10) will be included and bone samples from MCP joints analyzed using microcomputed tomography (µCT) and histology.

ELIGIBILITY CRITERIA

Inclusion criteria:

• Age > 18 years.
• Participants diagnosed with RA according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
• Indication for prosthesis surgery with total joint replacement of the MCP joint according to the clinical procedure (often radiological signs of osteoarthrosis (OA) in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).

Conditions

Arthritis, Rheumatoid

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Participants with RA

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Participants diagnosed with RA according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
• Indication for prosthesis surgery with total joint replacement of the MCP joint according to the clinical procedure (often radiological signs of OA in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).

Exclusion Criteria

• Unable to give written informed consent.
• Active malignant disease, hypercalcemia, poor kidney function (estimated glomerular filtration rate < 35 mL/min), untreated hypo-/hyperthyroidism, pregnancy or wish thereof, previously fracture/dislocation of the investigated joint or metal prosthesis in joints of the investigated hand.

Bone sample will be excluded from analysis, if the following is present:

• Bone not adequate for analysis (fractured bone samples).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen-Margrethe Hauge, Professor

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, Central Region of Denmark, Denmark

Regional Hospital Holstebro

Holstebro, Central Region of Denmark, Denmark

Countries

Denmark

Other Identifiers

675-897-002

Identifier Type: -

Identifier Source: org_study_id