CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Conditions
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Bimalleolar Ankle Fractures

Intervention / Treatment
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* Device: Active Combined Magnetic Field OL1000 Bone Growth Stimulator
* Device: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Group<br>Standard Rigid Fixation + Active OL1000 device | Device: Active Combined Magnetic Field OL1000 Bone Growth Stimulator<br>* Active CMF OL1000 Device<br>* Other names: CMF OL1000;|
| Sham Comparator: Control Group<br>Standard Rigid Fixation + Sham OL1000 device | Device: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator<br>* Sham CMF OL1000<br>* Other names: CMF OL1000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change overtime of Olerud and Molander Ankle Score (OMAS) |  | 6 weeks, 8 weeks, 10 weeks and 12 weeks | 
| Non-powered, composite safety endpoint consisting of: Joint Position Outcome Radiographic Failure and Repeat, Unplanned Surgery at the Operative Site and Device-Related Serious Adverse Events |  | 6 months & 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Growth Stimulator, Ankle Fracture