Examination of Biopsies From Healthy Knee Joints

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

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.

Study Overview

• Status: Terminated
• Conditions: Abnormality in Synovial Tissue

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, DK-9000
    • Northern Orthopaedic Division, Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cohorts will be selected from primary care clinic.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Novo Nordisk A/S
• Investigators: Study Chair: Sten Rasmussen, M.D., Northern Orthopaedic Division, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Estimate): June 1, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Inflammation; Rheumatoid arthritis; Synovial tissue; Joint destruction
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: N-20130026