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Dutch Artroscopic Society Rotator Cuff Study.


- candidate number4548
- NTR NumberNTR1545
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2008
- Secondary IDs07-116 METC Haaglanden Medical Center
- Public TitleDutch Artroscopic Society Rotator Cuff Study.
- Scientific TitleOpen versus arthroscopic treatment in patients with a full thickness rotator cuff rupture on MRI arthro.
- ACRONYMRotator cuff, repair, artroscopic
- hypothesisArtroscopic repair of a rotator cuff rupture is better than the open treatment.
- Healt Condition(s) or Problem(s) studiedTreatment, Rotator cuff, Arthroscopic
- Inclusion criteria1. Full thickness reparable rotator cuff rupture proven at MRI-arthro
2. Persisting shoulder complaints
3. Age 18-75 years
- Exclusion criteria1. Secondary cuff repair
2. Frozen shoulder
3. Reumatic disease
4. Shoulder instability
5. Previous shoulder intervention except infiltration
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2008
- planned closingdate1-jan-2011
- Target number of participants100
- InterventionsRandomisation in either arthroscopic fixation of the ruptured rotator cuff tendon at original insertion site or conventional open rotator cuff repair. - artroscopic cuff repair
- open cuff repair
- Primary outcome- DASH 12 months postoperative
- Secondary outcome- VAS
- NSST
- Constant Murley
- MR arthro
- rerupture
- complicaties
- Timepoints- preoperative
- 2 weeks po
- 6 weeks po
- 3 months po
- 6 months po
- 1 year po
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. B.J.W. Thomassen
- CONTACT for SCIENTIFIC QUERIESDrs. B.J.W. Thomassen
- Sponsor/Initiator Haaglanden Medical Center, The Hague
- Funding
(Source(s) of Monetary or Material Support)
Haaglanden Medical Center, The Hague
- PublicationsN/A
- Brief summaryRotator cuff ruptures are one of the most prevalent medical conditions concerning the musculoskeletal system with considerable morbidity. Operative intervention is indicated when conservative treatment fails. This can be done by the conventional open repair surgery or by an arthroscopic procedure. The arthroscopic procedure is upcoming but at this point it is not clear whether there is a difference with regard to pain and function after conventional open or arthroscopic rotator cuff surgery.
- Main changes (audit trail)
- RECORD21-nov-2008 - 19-mei-2014


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