|- candidate number||1201|
|- NTR Number||NTR124|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||21-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||The treatment of fresh scaphoid fractures with Pulsed Electromagnetic Fields (PEMF).|
|- Scientific Title||The treatment of fresh scaphoid fractures with Pulsed Electromagnetic Fields"
a prospective, double-blind, randomised multicentre study.|
|- hypothesis||The addition of PEMF to cast immobilisation in fresh scaphoid fractures will accelerate consolidation both clinically and radiologically. Possibly the incidence of non-union will be reduced.|
|- Healt Condition(s) or Problem(s) studied||Scaphoid fracture |
|- Inclusion criteria||1. Unilateral fresh scaphoid fracture;|
2. Fracture type's: A1, A2, A3, B1, B3
|- Exclusion criteria||1. Pregnancy;|
2. Presence of life supporting implanted electronical device;
3. Fracture of distal radius/ulna, the carpals or metacarpal bones;
4. Pre-existing impairment in wrist motion.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-sep-2007|
|- Target number of participants||230|
|- Interventions||All patients suspected of having a fresh scaphoid fracture will be treated with cast immobilisation. |
Scaphoid fracture is diagnosed by a combination of physical and radiographic examination. If no apparent fracture line is seen on the initial X-rays, a Technetium scan will be performed (3-6 days after injury) to confirm the diagnosis.
The PEMF device (supplied by commercial support) will be placed on the cast within one week and will be applied for 24 hours a day continuously. The cast will be a lower arm cast with the first metacarpal bone immobilised.
Since the position of the thumb and the hand have no adverse effect on the displacement of the fracture or itís consolidation, this neutral plaster is choosen.14,15
Half of the PEMF devices will be disabled at random in the factory. These disabled devices will give outward signs of normal function but will not generate a signal. The investigators will be unaware of the deviceís functionality.
At study completion, device serial numbers will be used to determine which patients received a working device.
Follow up will take place at four, six, twelve and twenty-four weeks after diagnosis of the fractured scaphoid.
When the fracture has both clinically and radiologically consolidated the plaster will be removed.
If the fracture has not consolidated; a new plaster will be made. Only patients who need immobilisation of the fracture (not consolidated fractures) will have a PEMF device on them, for in clinically and radiographically consolidated patients there is no need for further treatment. If consolidation was established before, it can be checked at later follow up dates if that conclusion wasnít premature. If the fracture is not consolidated after twelve weeks, at physical or radiographic examination, yet the patient has no pain the treatment is finished. If the patient has got pain, he will get a removable splint.
All tests will be compared with the opposite unaffected side. In addition to the physical and radiographic examination, patients will be required to fill in two questionnaires: an SF health survey 36 and the McGill Pain Questionnaire ( multidimensional description of the patientís feelings of pain).
|- Primary outcome||Consolidationn of the fracture:|
at 4, 6, 12 and 24 weeks after inclusion the patients will be examined (both radiologically and physically) and will be asked to fill in the questionnaires.
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| B.J. Wely, van|
|- CONTACT for SCIENTIFIC QUERIES|| B.J. Wely, van|
|- Sponsor/Initiator ||Innovative Medical Devices Ė IMD B.V. |
(Source(s) of Monetary or Material Support)
|- Brief summary||With the results of this study we want to investigate whether fresh scaphoid fractures consolidate faster when a PEMF device is used. |
Studies performed by other groups show accelerated consolidation of 30 % when this non-invasive technique is used in combination with standard immobilisation. However no double blind, randomised trials have been conducted.
The aim of this study is to determine whether the use of PEMF in fresh scaphoid fractures will accelerate consolidation both clinically and radiologically, and whether the use of PEMF reduces the incidence of nonunion (for which secondary surgical intervention is needed).
|- Main changes (audit trail)|
|- RECORD||14-aug-2005 - 5-jan-2010|