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Active Combined Magnetic Field OL1000 Bone Growth Stimulator for Bimalleolar Ankle Fractures

N/A
Waitlist Available
Research Sponsored by Encore Medical, L.P.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

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.

Eligible Conditions
  • Bimalleolar Ankle Fractures

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational GroupExperimental Treatment1 Intervention
Standard Rigid Fixation + Active OL1000 device
Group II: Control GroupPlacebo Group1 Intervention
Standard Rigid Fixation + Sham OL1000 device

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Who is running the clinical trial?

Encore Medical, L.P.Lead Sponsor
21 Previous Clinical Trials
3,385 Total Patients Enrolled
~25 spots leftby Nov 2025
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