The treatment of fresh scaphoid fractures with Pulsed Electromagnetic Fields (PEMF)
| ISRCTN | ISRCTN50724986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50724986 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 15/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B.J. van Wely
Scientific
Scientific
Veemarkt 129
Nijmegen
6511 ZD
Netherlands
| Phone | +31 (0)64 176 7608 |
|---|---|
| bobvanwely@yahoo.com |
Study information
| Study design | Multicentre, randomised, double blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The treatment of fresh scaphoid fractures with Pulsed Electromagnetic Fields (PEMF) |
| Study objectives | 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. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Scaphoid fractures |
| Intervention | 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 its consolidation, this neutral plaster is choosen. 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 devices 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 wasnt 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: 1. 36-item Short Form health survey (SF-36) 2. The McGill Pain Questionnaire (multidimensional description of the patients feelings of pain) |
| Intervention type | Other |
| Primary outcome measure | Consolidation 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 measures | No secondary outcome measures |
| Overall study start date | 01/09/2005 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 230 |
| Key inclusion criteria | 1. Unilateral fresh scaphoid fracture 2. Fracture types: A1, A2, A3, B1, B3 (Herbert Classification) |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Veemarkt 129
Nijmegen
6511 ZD
Netherlands
6511 ZD
Netherlands
Sponsor information
Innovative Medical Devices (IMD) B.V. (The Netherlands)
Industry
Industry
P.O. Box 153
Amsterdam
5400 AD Uden
Netherlands
| Website | http://www.imd-eur.com/index.asp |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/10/2012 | 15/07/2021 | Yes | No |
Editorial Notes
15/07/2021: Publication reference added.
