CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Status:	Recruiting
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	21 - Any
Updated:	1/24/2018
Start Date:	January 23, 2017
End Date:	June 2019

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

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.

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

We found this trial at

sites

Cedars-Sinai Medical Center

8700 Beverly Blvd # 8211
Los Angeles, California 90048

(1-800-233-2771)