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CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

NCT02688855 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2022-03-21

No results posted yet for this study

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.

Conditions

  • Bimalleolar Ankle Fractures

Interventions

DEVICE

Active Combined Magnetic Field OL1000 Bone Growth Stimulator

Active CMF OL1000 Device

DEVICE

Sham Combined Magnetic Field OL1000 Bone Growth Stimulator

Sham CMF OL1000

Sponsors & Collaborators

  • Encore Medical, L.P.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2022-03-31
Completion
2022-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02688855 on ClinicalTrials.gov