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Examination of Biopsies From Healthy Knee Joints

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ClinicalTrials.gov Identifier: NCT02458170
Recruitment Status : Terminated (Shutdown of The Department of Inflammatory Diseases at Novo Nordisk.)
First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Examination of Biopsies From Healthy Knee Joints for the Use of Research Activities in Inflammatory Joint Diseases
Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adverse events as a measure of metabolism in normal tissue and inflammatory tissue. [ Time Frame: 7 years ]
    Compare the normal metabolism in non-inflammatory tissue with biopsies of inflammatory diseases.


Secondary Outcome Measures :
  1. Detect new objects for developing drugs. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Biopsies from synovial tissue.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cohorts will be selected from primary care clinic.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458170


Locations
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Denmark
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, Denmark, DK-9000
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Novo Nordisk A/S
Investigators
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Study Chair: Sten Rasmussen, M.D. Northern Orthopaedic Division, Aalborg University Hospital
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Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT02458170    
Other Study ID Numbers: N-20130026
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015
Keywords provided by Northern Orthopaedic Division, Denmark:
Rheumatoid arthritis
Synovial tissue
Joint destruction
Inflammation
Additional relevant MeSH terms:
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Congenital Abnormalities