CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Clinical Trial 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.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02688855
Study type	Interventional
Source	Encore Medical, L.P.
Contact	Akujuobi Udu, MS
Phone	248-914-0150
Email	akujuobi.udu@djoglobal.com
Status	Recruiting
Phase	N/A
Start date	January 23, 2017
Completion date	June 2022

CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms