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TightRope AcromioClavicular Study; TRACS.


- candidate number5668
- NTR NumberNTR1783
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2009
- Secondary IDs09-052 METC Medical Center Haaglanden
- Public TitleTightRope AcromioClavicular Study; TRACS.
- Scientific Title´Operative TightRope stabilisation versus conservative treatment of Rockwood III acromioclavicular luxations.'
- ACRONYMTRACS
- hypothesisAcute Rockwood type 3 AC-luxations will have a better function after operative treatment with the artroscopic TightRope technique than patients treated conservative.
- Healt Condition(s) or Problem(s) studiedAcromioclavicular luxation, Shoulder instability
- Inclusion criteria1. AC-dislocation Rockwood type 3 confirmed with CT scan;
2. Presentation within 6 weeks after trauma;
3. Patients older than 18 years;
4. Patients with signed informed consent.
- Exclusion criteria1. Age younger than 18 years;
2. Glenohumeral instability;
3. Other fractures to the shoulder joint;
4. Frozen shoulder;
5. Earlier attempt to fixate AC;
6. Non compliance.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate1-jul-2011
- Target number of participants50
- Interventions1. Operative treatment with artroscopic TightRope system;
2. Conservative treatment with slinge and physiotherapy.
- Primary outcomeDASH score 6 months and 1 year.
- Secondary outcome1. VAS painscore;
2. NSST;
3. Constant Murley score.
- TimepointsPostoperative 6 weeks, 3 months, 6 months and 1 year.
- Trial web sitewww.mchaaglanden.nl/orthopedie
- statusstopped
- CONTACT FOR PUBLIC QUERIESDrs. B.J.W. Thomassen
- CONTACT for SCIENTIFIC QUERIESDrs. B.J.W. Thomassen
- Sponsor/Initiator Medical Center Haaglanden, Sint Antonius Ziekenhuis, Spaarne Hospital
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsJansen JA, Arkel van ERA. Artroscopische stabilisatie van acute acromioclaviculaire luxatie - beschrijving van een nieuwe techniek en eerste resultaten. Ned Tijdschrift v Orthopedie Dec 2007, vol 14 (4): 143-47.
- Brief summaryAcromio-clavicular (AC) dislocation is often caused by a fall on the shoulder in younger patients. The treatment of these acute luxations is still on debate also because differences in seriousness. New artroscopic treatment makes it possible to fixate AC without large surgical procedure. Maybe this intervention makes it possible to receive consensus on treatment of Rockwood fractures.
- Main changes (audit trail)
- RECORD28-apr-2009 - 9-sep-2010


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