Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union

Nanjing University

Status and phase: Completed; Phase 4

Conditions: Fracture; Delayed Union of Fracture

Treatments: Device: pulsed electromagnetic field; Device: sham

Study type: Interventional

Funder types: Other

Identifiers

NCT01574833

QYK10147

Details and patient eligibility

About

The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.

Enrollment: 92 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The failure of healing after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture.

Exclusion criteria

• Implant loosening or failure, infection, established nonunion, fracture gap greater than 5 mm, presence of implant within the fracture gap, metabolic disorders or received medication affecting fracture healing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

PEMF

Active Comparator group

Description:

arm that receive PEMF treatment

Treatment:

Device: pulsed electromagnetic field

Sham

Sham Comparator group

Description:

arm that receive sham treatment

Treatment:

Device: sham