Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B.J. van Wely

ORCID ID

Contact details

Veemarkt 129
Nijmegen
6511 ZD
Netherlands
+31 (0)64 176 7608
bobvanwely@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, double blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 it’s 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 device’s 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 wasn’t 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 patient’s feelings of pain)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2005

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Unilateral fresh scaphoid fracture
2. Fracture types: A1, A2, A3, B1, B3 (Herbert Classification)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

230

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Veemarkt 129
Nijmegen
6511 ZD
Netherlands

Sponsor information

Organisation

Innovative Medical Devices (IMD) B.V. (The Netherlands)

Sponsor details

P.O. Box 153
Amsterdam
5400 AD Uden
Netherlands

Sponsor type

Industry

Website

http://www.imd-eur.com/index.asp

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes