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Kracht en functie na een omgekeerde schouderprothese


- candidate number30222
- NTR NumberNTR7693
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2018
- Secondary IDs19-016 
- Public TitleKracht en functie na een omgekeerde schouderprothese
- Scientific TitleDeltoid volume and strength following reverse shoulder arthroplasty
- ACRONYMdeltoid volume
- hypothesisPostoperative change in deltoid volume following reverse shoulder arthroplasty is related to functional outcome
- Healt Condition(s) or Problem(s) studiedShoulder prothesis, Arthrosis, Cuff arthropathy, Shoulder disorders
- Inclusion criteriaReversed schouderprothese geplaatst in ons ziekenhuis tussen 01-01-2006 en 01-01-2017.
- Exclusion criteria- Leeftijd onder de 18 jaar.
- Niet beheersen van de Nederlandse taal.
- Revisie- of fractuurprothese.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2019
- planned closingdate1-jul-2020
- Target number of participants100
- Interventions-
- Primary outcomeRelation in postoperative change in deltoid volume and Constant Murley score
- Secondary outcomeOxford Shoulder score, range of motion (abduction, anteflexion, glenohumeral abduction, external rotation, internal rotation, abduction+external rotation), relation in postoperative change in deltoid volume and change in distalisation of the humeral head on pre- and postoperative Xrays
- Timepoints-
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Friso de Boer
- CONTACT for SCIENTIFIC QUERIES Friso de Boer
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryRemain of a proper function and strength of the deltoid muscle is an important theoretical factor in long term results after reversed shoulder arthroplasty. Because of the changed non-anatomical biomechanical situation following reversed arthroplasty, there are doubts about the resistency of the deltoid muscle against this changed situation. Therefore we perform an observational clinical study in patients following reversed shoulder arthroplasty after 2-13 years of followup. Deltoid volume, strength, range of motion and clinical outcome scores are measured. We hypothesize that a postoperative decrease in volume of the deltoid muscle has a negative effect on clinical outcome scores.
- Main changes (audit trail)
- RECORD5-dec-2018 - 6-jan-2019


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