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Onthullen van moleculaire en cellulaire mechanismen die verband houden met veroudering van de schouderspieren en het optreden van een rotator cuff scheur.


- candidate number19264
- NTR NumberNTR4725
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-aug-2014
- Secondary IDsP13.093 METC Leiden 44516 CCMO
- Public TitleOnthullen van moleculaire en cellulaire mechanismen die verband houden met veroudering van de schouderspieren en het optreden van een rotator cuff scheur.
- Scientific TitleUnraveling the molecular and Cellular muscular mechanisms associated with Aging in rotator cuff Tears of the Shoulder
- ACRONYMCATS
- hypothesisAge associated molecullar processess are involved in rotator cuff degeneration and the presence of rotator cuff tears
- Healt Condition(s) or Problem(s) studiedRotator cuff
- Inclusion criteriaMRI proven shoulder pathology for which shoulder surgery is needed.
- Exclusion criteria- Age < 18 and > 80 years
- No informed consent
- Comorbidity: neurological disorders (stroke, M. Parkinson, dementia, muscle disease), rheumatoid arthritis, polymyalgia rheumatic, heart failure, COPD (Gold III-IV), chronic pain syndrome (fibromyalgia, complex regional pain syndrome etc)
- Metabolic diseases (e.g. insuline dependent DM)
- Cancer
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 19-jun-2014
- planned closingdate1-sep-2019
- Target number of participants80
- Interventionsbiopsies of subscapular muscle and deltoid muscle
- Primary outcomeRNA profiling difference between subscapular and deltoid muscles and its correlation to magnetic resoncace imaging
- Secondary outcomecell proliferation
cell apoptosis
mitochondrial activity
cell fusion
cell senescence
Constant score
Range of motion
Muscle Strength
DASH
WORC
MR features including:
- fatty infiltration
- cross sectional surface area
- Timepointsonly at baseline/during surgery.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R.G.H.H. Nelissen
- CONTACT for SCIENTIFIC QUERIESDr. R.G.H.H. Nelissen
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-aug-2014 - 2-sep-2014


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