Skip to content

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. Clinical and radiological outcome. A multicentre, prospective, double-blind, placebo-controlled, randomized trial. (CMO nr 2009/196) (ABR nr NL27191.091.09).

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. Clinical and radiological outcome. A multicentre, prospective, double-blind, placebo-controlled, randomized trial. (CMO nr 2009/196) (ABR nr NL27191.091.09).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27135
Enrollment
110
Registered
2009-10-23
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

scaphoid fracture, bone growth stimulation, electromagnetic fields, fracture healing, ununited fracture, double-blind method

Interventions

Bone growth stimulation by means of pulsed electromagnetic fields (PEMF). Both arms receive a stimulator attached to their scaphoid. In one group however, the stimulator has been eliminated by the man

Sponsors

ZonMW, academisch ziekenhuis Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All unilateral scaphoid fractures, types A1, A2, B1, B2 and B3.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Presence of a life-supporting implanted electronical device; 3. Additional fractures of wrist, carpal or metacarpal bones; 4. Pre-existing impairment in wrist function.

Design outcomes

Primary

MeasureTime frame
Radiological proof of union of the scaphoid fracture at six weeks after initiation of the electromagnetic stimulation, determined by means of CT-scanning.

Secondary

MeasureTime frame
1. Radiological and clinical consolidation at 24 weeks (non-union ?); 2. Functional outcome and quality of life at 52 weeks.

Contacts

Public ContactP.F.W. Hannemann

po box 5800

+31 (0)43 3875491

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)