Pulsed electromagnetic fields in the treatment of fresh scaphoid fractures. Clinical and radiological outcome. A multi centre, prospective, double-blind, placebo controlled, randomized trial.

Pulsed electromagnetic fields in the treatment of fresh scaphoid fractures. Clinical and radiological outcome. A multi centre, prospective, double-blind, placebo controlled, randomized trial. - Pulsed electromagnetic fields in the treatment of fresh scaphoid fractures.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33275

Enrollment

110

Registered

2009-09-21

Start date

2010-01-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healing disorder scaphoid non-union

Interventions

All patients having a proven scaphoid fracture are treated with cast immobilisation and a small PEMF device placed on the cast. Half of the PEMF devices will be disabled at random in the factory. Th

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All unilateral fresh scaphoid fractures, types A1, A2, B2 and B3 (all stable and unstable acute fractures except the dislocated and comminuted ones) according to the Herbert classification of scaphoid fractures.

Exclusion criteria

Exclusion criteria: Exclusion criteria are pregnancy, presence of a life-supporting implanted electronical device, additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function.

Design outcomes

Primary

Measure	Time frame
Primary endpoint is number of scaphoid fracture unions (healed fractures) at six weeks.	—

Secondary

Measure	Time frame
Secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)