CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Encore Medical

Status: Unknown

Conditions: Bimalleolar Ankle Fractures

Treatments: Device: Active Combined Magnetic Field OL1000 Bone Growth Stimulator; Device: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02688855

PS-607

Details and patient eligibility

About

The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization. The initiation of the adjunctive treatment is to begin within 11 days of surgical stabilization.

Enrollment: 217 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is diagnosed with an unstable, closed, isolated fracture of the ankle and underwent operative stabilization with plate(s) and/or screws (Weber Ankle Fracture Classification B and C)

Exclusion criteria

• Subject has an open fracture
• Subject has any additional fractures of another bone besides the ankle fracture that is to be treated in the study including the contralateral ankle
• Surgical stabilization was definitively performed with an external fixation system
• Surgical stabilization was performed in such a manner that it will result in a fusion of the ankle joint
• Malreduced Ankle as described by Phillips, et al 1985 JBJS
• Surgical procedure included the use of osteoinductive materials in addition to rigid fixation
• BMI ≥ 40 kg/m2

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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217 participants in 2 patient groups

Investigational Group

Experimental group

Description:

Standard Rigid Fixation + Active OL1000 device

Treatment:

Device: Active Combined Magnetic Field OL1000 Bone Growth Stimulator

Control Group

Sham Comparator group

Description:

Standard Rigid Fixation + Sham OL1000 device

Treatment:

Device: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator