Ankle Fractures—Bone Growth Stimulation After Surgery

Condition: Ankle Fractures

Eligibility

Key Inclusion Criteria

  • Diagnosed with an unstable, closed, isolated fracture of the ankle and underwent operative stabilization with plate(s) and/or screws
  • At least 21 years old
  • Able to begin treatments with the bone growth stimulation unit within 11 days of surgical stabilization

Key Exclusion Criteria

  • Has an open fracture
  • Has any additional fractures of another bone besides the ankle fracture that will be treated in the study including the contralateral ankle
  • Surgical stabilization definitively performed with an external fixation system

Full Study Name

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 (IRB no. 46350) 

Summary

This study focuses on individuals who have had a fresh, closed, unstable ankle fracture that required surgery. The purpose of the study is to evaluate the safety and effectiveness of the CMF OL1000 Bone Growth Stimulator device for unstable ankle fractures that require surgical intervention for stabilization. Researchers aim to determine whether the OL1000 will help patients with this type of ankle fracture heal more quickly after surgery. The OL1000 is a nonsurgical device that uses a very low-strength, combined magnetic field to activate the body’s natural healing process.

When a human bone is bent or broken, it generates an electrical field. This low-level, electrical field activates the body’s internal repair mechanism, which in turn stimulates bone healing. Sometimes this healing process is impaired and may not mend properly. The use of the OL1000 in this study is investigational.

Phase
Phase III


Principal Investigator

Charles Moon, MD

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