Clinical trial NCT02458170: Examination of Biopsies From Healthy Knee Joints
Official title: Examination of Biopsies From Healthy Knee Joints for the Use of Research Activities in Inflammatory Joint Diseases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abnormality in Synovial Tissue
Keywords: Rheumatoid arthritis
Synovial tissue
Joint destruction
Inflammation
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2015-06-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohorts will be selected from primary care clinic.

Brief summary: The purpose of the project is to examine what kind of molecular mechanism which causes inflammatory joint diseases. This examination is carried out by a collection and analysis of synovial tissues for patients without inflammatory joint diseases compared to the experienced equivalent biopsies from patients with inflammatory joint diseases.

Detailed description: Arthritis is caused by autoimmune disease in the cells and pathogenesis of the tissue. This autoimmune inflammation is very often a chronic disease which causes irreversible articular damage. Rheumatoid arthritis is very often a painful and disabling disease if the treatment turns out to be ineffectual. Several of the available remedies can not treat the disease totally but only keep the patients in check.

The biological mechanisms which cause an autoimmune inflammatory articular disease have not been proved scientifically yet. Under normal conditions, the immune system adapts easily in order to protect the body against pathogenic bacteria and virus without causing damage on the body's own cells. Autoimmune inflammatory diseases displace this balance in a way so that the immune system can not distinguish between "self" and "non-self". Different kinds of cells are involved in this chronic inflammation in the joints. Majority of these cells belong to the heart of the immune response, for example T-lymphocytes, B-lymphocytes, macrophages, dendrites and granulocytes. However, other cells are also involved, for example synovial fibroblasts and endothelium.

It is very important to understand the interaction of these cells in order to develop new medicinal products for inflammatory articular diseases. The big challenge for conduction research in inflammatory articular diseases is to achieve more evidence-based knowledge of the synovial tissue from the patients and the control group.

Eligibility criteria: Inclusion Criteria:

* Males and females \> 18 years
* Planned surgery for patients with meniscus or reconstruction of ligament

Exclusion Criteria:

* Employment at Aalborg University Hospital
* Employment at Novo Nordisk A/S
* An unsigned statement of consent
* Current medical treatment resistant to a course of treatment, for example large doses of steroids

Primary outcomes:
measure: Adverse events as a measure of metabolism in normal tissue and inflammatory tissue.
timeFrame: 7 years
Secondary outcomes:
measure: Detect new objects for developing drugs.
timeFrame: 7 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Aalborg University Hospital
Study officials:
affiliation: Northern Orthopaedic Division, Aalborg University Hospital
name: Sten Rasmussen, M.D.
role: STUDY_CHAIR
References: