Examination of Biopsies From Healthy Knee Joints

Abnormality in Synovial Tissue Clinical Trial

Official title:

Examination of Biopsies From Healthy Knee Joints for the Use of Research Activities in Inflammatory Joint Diseases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02458170
• Other study ID #: N-20130026
• Status: Terminated
• Phase: N/A
• First received: September 12, 2014
• Last updated: May 29, 2015
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abnormality in Synovial Tissue

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events as a measure of metabolism in normal tissue and inflammatory tissue.	Compare the normal metabolism in non-inflammatory tissue with biopsies of inflammatory diseases.	7 years	Yes
Secondary	Detect new objects for developing drugs.	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.	7 years	Yes