|- candidate number||10471|
|- NTR Number||NTR3113|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-okt-2011|
|- Secondary IDs||NL 37754 ABR|
|- Public Title||VIPER, operatie versus gips bij polsfracturen.|
|- Scientific Title||Volar Internal Plate fixation vs. plaster in Extra- articulair distal Radial fractures.|
|- hypothesis||Anatomic reduction and stable fixation of distal radius fractures by volar plating allows for early mobilization and therefore leads to a better function.|
|- Healt Condition(s) or Problem(s) studied||Distal radius fracture|
|- Inclusion criteria||1. Patients >18 years <75;|
2. AO type A displaced distal radius fracture;
3. Fracture displacement is defined by the AO foundation as fragments not perfectly anatomically aligned;
4. Acceptable closed reduction obtained immediately after presentation at the Emergency Department (<12hrs).
|- Exclusion criteria||1. Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb;|
2. Open distal radius fractures;
3. Multiple trauma patients;
4. Other fractures in the affected extremity;
5. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician;
6. Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Pagetís disease, renal osteodystrophy, osteomalacia);
7. Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfanís, Ehler Danlos or other related disorders.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-mrt-2017|
|- Target number of participants||90|
|- Interventions||This study will randomise between open reduction and internal fixation with a volar locking plate and plaster immobilisation. |
|- Primary outcome||Patient-Rated Wrist Evaluation score (PRWE). |
|- Secondary outcome||Seconday outcome: Disabitly Arm Shoulder Hand Score (DASH), quality of life (QoL SF-36), pain as indicated on a Visual Analogue Scale (VAS), Range of Motion (ROM), radiological outcome and complications.|
|- Timepoints||1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year.|
|- Trial web site||www.viperstudie.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD Marjolein A.M. Mulders |
|- CONTACT for SCIENTIFIC QUERIES||MD PhD N.W.L. Schep|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Rationale: |
The ideal treatment for extra-articular distal radius fractures remains a controversial issue. Excellent results have been described both in patients treated with a plaster and in patients treated with open reposition and internal fixation (ORIF) with a volar locking plate. Recently, the use of Volar Locking Plates has become more popular, due to its better performance in osteoporotic bone. Moreover, anatomic reduction and stable fixation of these fractures allows for early mobilization and may theoretically lead to a better function.
To compare the functional outcome of ORIF with a volar locking plate to closed reduction and plaster immobilisation in patients with extra-articular distal radius fractures.
Multi Center Randomized Controlled Trial.
All consecutive adult patients with an AO type A distal radius fracture which was successfully reduced within 12 hrs of presentation at Emergency department of the participating hospitals.
This study will randomise between open reduction and internal fixation with a volar locking plate and plaster immobilisation.
Main study parameters/endpoints:
Primary outcome: Patient-Rated Wrist Evaluation score (PRWE). Seconday outcome: Disabitly Arm Shoulder Hand Score (DASH), quality of life (QoL SF-36), pain as indicated on a Visual Analogue Scale (VAS), Range of Motion (ROM), radiological outcome and complications.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be asked to return to the hospital for follow up at; one, three and six weeks and three, six and twelve months. During these visits patients will be asked about any complaints and/or complications and physical examination will be performed. The risks associated with the treatment under study comprise standard risk for undergoing a surgical procedure related to anaesthesia, post-operative pain and wound infection.
|- Main changes (audit trail)|
|- RECORD||22-okt-2011 - 25-nov-2016|