Clinical trial NCT04645381: Bone Erosions in Rheumatoid Arthritis - Characterization Evaluated by Imaging and Histology
Official title: Bone Erosions in Rheumatoid Arthritis - Characterization Evaluated by Imaging and Histology
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
High-resolution peripheral quantitative computed tomography
Radiography
Micro computed tomography
Histology
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2020-11-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with RA are recruited in conjunction with a routine visit at the Department of Orthopedic Surgery at Aarhus University Hospital or at the Regional Hospital Holstebro for assessment of surgical indication for joint replacement surgery on MCP joints by a specialist in orthopedic surgery.

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).

Eligibility criteria: RA Participants:

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).

Primary outcomes:
measure: Transcortical vessels and pores.
timeFrame: within 24 weeks after inclusion
Secondary outcomes:
measure: The bare area
timeFrame: within 24 weeks after inclusion
measure: Bone erosions
timeFrame: within 24 weeks after inclusion
Other outcomes:
measure: Microarchitecture
timeFrame: within 24 weeks after inclusion
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Region Of Denmark
city: Holstebro
country: Denmark
facility: Regional Hospital Holstebro
state: Central Region Of Denmark
Study officials:
affiliation: Aarhus University Hospital
name: Ellen-Margrethe Hauge, Professor
role: STUDY_DIRECTOR
References: