Examination of Biopsies From Healthy Knee Joints

Terminated

• Conditions: Abnormality in Synovial Tissue

• Registration Number: NCT02458170
• Lead Sponsor: Northern Orthopaedic Division, Denmark

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-09-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-29
• Last Update Submitted: 2015-05-29
• Study First Posted: 2015-06-01
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events as a measure of metabolism in normal tissue and inflammatory tissue.	7 years	Compare the normal metabolism in non-inflammatory tissue with biopsies of inflammatory diseases.

Secondary Outcome Measures

Name	Time	Method
Detect new objects for developing drugs.	7 years	Determine potential objects for medical intervention and development of drugs which affect the molecular mechanisms in relation to an inflammatory condition versus a normal metabolic condition.

Trial Locations

Locations (1)

Northern Orthopaedic Division, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark