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

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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
9
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-829-3613
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-1620
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Phone: 585-276-7790
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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Hollywood, Florida 33021
Phone: 954-854-3463
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Hollywood, FL
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65 Bergen Street
Newark, New Jersey 07103
Phone: 973-972-2184
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Newark, NJ
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3464 Avalon Park East Boulevard
Orlando, Florida 32828
Phone: 321-841-3867
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Orlando, FL
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Royal Oak, Michigan 48073
Phone: 248-551-0194
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Royal Oak, MI
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Tucson, Arizona 85721
(520) 621-2211
Phone: 520-626-5472
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tucson, AZ
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300 Polaris Parkway
Westerville, Ohio 43082
Phone: 614-895-8747
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Westerville, OH
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