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

Active, not recruiting

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT04645381
• Lead Sponsor: University of Aarhus

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).

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-27
• Status Verified: 2024-05
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-11
• Study Completion: 2035-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transcortical vessels and pores.	within 24 weeks after inclusion	To identify and describe transcortical vessels and pores at the bare area in MCP joints from RA patients and describe the location, number, and compare intra- and extra-articularly by histology, μCT, and HR-pQCT.

Secondary Outcome Measures

Name	Time	Method
The bare area	within 24 weeks after inclusion	To identify and describe the bare area in MCP joints from RA patients macroscopically, with imaging (HR-pQCT, conventional X-ray, μCT), and histology.
Bone erosions	within 24 weeks after inclusion	To identify bone erosions by conventional X-ray, μCT, and HR-pQCT and assess inflammatory infiltrates using histology in RA patients.

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Region Of Denmark, Denmark

Regional Hospital Holstebro; 🇩🇰 Holstebro, Central Region Of Denmark, Denmark