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Examination of Biopsies From Healthy Knee Joints

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Novo Nordisk A/S
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Tracking Information
First Submitted Date September 12, 2014
First Posted Date June 1, 2015
Last Update Posted Date June 1, 2015
Study Start Date August 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2015)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 29, 2015)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Biopsies from synovial tissue.
Sampling Method Probability Sample
Study Population Cohorts will be selected from primary care clinic.
Condition Abnormality in Synovial Tissue
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 29, 2015)
Original Actual Enrollment Same as current
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
Administrative Information
NCT Number NCT02458170
Other Study ID Numbers N-20130026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Northern Orthopaedic Division, Denmark
Study Sponsor Northern Orthopaedic Division, Denmark
Collaborators Novo Nordisk A/S
Study Chair: Sten Rasmussen, M.D. Northern Orthopaedic Division, Aalborg University Hospital
PRS Account Northern Orthopaedic Division, Denmark
Verification Date May 2015