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Lange termijn resultaten van een gerandomiseerde studie tussen 2 type schouderoperaties (acromionplastiek +bursectomie versus bursectomie alleen)


- candidate number19262
- NTR NumberNTR4723
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-aug-2014
- Secondary IDsP14.059 METC Zuid-West 49198 CCMO
- Public TitleLange termijn resultaten van een gerandomiseerde studie tussen 2 type schouderoperaties (acromionplastiek +bursectomie versus bursectomie alleen)
- Scientific TitleLong-term rEsults of acromioplasty versus bursectomy in the treatment of Subacromial Impingement Syndrome. - Clinical and radiological outcome after 8-13 years-
- ACRONYMLESIS
- hypothesisPatients with SIS treated with bursectomy in combination with acromioplasty have higher mid-term Constant scores than patients treated with bursectomie alone.
- Healt Condition(s) or Problem(s) studiedComplaints of shoulder, Subacromial impingement syndrome, Rotator cuff
- Inclusion criteriaPatients who are randomised between bursectomy alone and bursectomy in combination with acromionplasty by Henkus et al 2009. This study is a follow-up study of previous randomized and treated patients.

Definition of Subacromial impingement syndrome (SIS):
- Positive Neer or Hawkins test
- Inability to lie on the affected side
- No other diagnose that may cause subacromial pain on MRA.
- Exclusion criteria-Trauma in history (i.e. traumatic begin of symptoms and fracture)
- Prior surgery of the affected limb
-Limited passive range of motion (i.e. frozen shoulder)
- Full and partial thickness rotator cuff tears
- Calcifying tendinitis
- Biceps tendinopathy
- Clinical gleno-humoral instability (i.e. uni- and multidirectional or labrum pathology)
- Glenohumoral artritis (i.e. rheumatoid or osteo-artritis)
- Acromioclavicular (osteo)artritis (i.e. radiologic osteoarthritis in combination with compression pain at the AC joint)
- Cervical radiculopathy
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-jul-2014
- planned closingdate1-jul-2018
- Target number of participants56
- InterventionsMagnetic Resonance imaging plus Arthrography
- Primary outcomeConstant score
- Secondary outcomeVisual analogue scale for pain. Western Ontario Rotator Cuff Index. Simple Shoulder Test. Anchor questions regarding satisfaction reported on a Likert scale.
- Timepoints8-13 years postoperatively
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Arkel, van
- CONTACT for SCIENTIFIC QUERIESDr. R.G.H.H. Nelissen
- Sponsor/Initiator Medical Center Haaglanden, 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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