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PROMOTION-trial: onderzoek naar 2 verschillende chirurgische methoden om een verplaatste breuk van de bovenarm te behandelen.


- candidate number14949
- NTR NumberNTR4019
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2013
- Secondary IDsNL40644.068.12 METC azm/UM
- Public TitlePROMOTION-trial: onderzoek naar 2 verschillende chirurgische methoden om een verplaatste breuk van de bovenarm te behandelen.
- Scientific TitlePROMOTION-trial: A PROspective randomized Multicenter trial for the treatment of dislocated 3-part proximal humerus fractures: Open reduction and internal fixaTION versus intramedullary nailing.
- ACRONYMPROMOTION-trial
- hypothesisIntramedullary nailing with the T2 proximal humerus nail results in higher Constant-Murley Score after 1 year compared with open reduction and internal fixation with the Philos plate.
- Healt Condition(s) or Problem(s) studiedhumerus fracture
- Inclusion criteria1. Adult men and women aged 18 years or older;
2. Unilateral acute dislocated three-part proximal humeral fracture (>45 degrees of angulation or > 0,5 cm of dislocation between major fracture fragments);
3. Fit for surgery;
4. Operative treatment within 21 days post-fracture;
5. Provision of informed consent by patient.
- Exclusion criteria1. bilateral proximal humeral fractures;
2. other major trauma / fractures;
3. pathological, recurrent or open fractures;
4. pre-existing impaired shoulder function (i.e., stiff or painful shoulder, neurologic disorder of the upper limb, or diagnosed rotator cuff impairment;
5. Retained hardware around the affected humerus;
6. a disorder of bone metabolism other than osteoporosis (i.e., Pagetís disease, renal osteodystrophy, osteomalacia);
7. Moderate or severe cognitively impaired patients (i.e., Mini-Mental Status Examination (MMSE) Six Item Screener with 3 or more errors);
8. Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., patients with no fixed address will be excluded);
9. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information in the judgment of the attending physician;
10. Patients with follow-up in other then the participating hospitals.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2013
- planned closingdate31-jul-2017
- Target number of participants92
- InterventionsPatients with a 3-part displaced proximal humeral fracture have an indication for surgical treatment. Until now there is no superior technique. Therefore patients will be randomized for osteosynthesis using the Philos plate (Proximal humeral internal locking system, Synthes) or PHN (Proximal Humeral Nailing system, Stryker).
The primary outcome is the Constant-Murley score after 1 year of follow-up. This is the recommended score to express schoulder function. The intervention is the only difference between the 2 groups. Follow-up duration and schedule is similar.
- Primary outcomePrimary endpoint is functional outcome 1 year after surgery indicated by the Constant-Murley scale.
- Secondary outcomeSecundary outcomes are DASH-score, pain, SF-12, EQ-5D, complication and mortality rate.
- Timepoints2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 year after surgery
- Trial web sitetoetsingonline.ccmo.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD Jeroen Bransen
- CONTACT for SCIENTIFIC QUERIESMD Jeroen Bransen
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht Universitair Medisch Centrum (MUMC+)
- PublicationsN/A
- Brief summaryWith an aging population the incidence of humerusfractures will rise. Dislocated 3-part proximal humerus fractures are treated either by open reduction and internal plate-fixation (Philos, Synthes) or by intramedullary nailing (T2 PHN, Stryker). Until now there have been no randomized controlled trials to proof one of these methods to be superior. The goal of this trial is to point out the surgical intervention with the best functional outcome, measured in Constant-Murley score after 1 year.
- Main changes (audit trail)
- RECORD3-jun-2013 - 8-jul-2013


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