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.
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
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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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60 Crittenden Blvd # 70
Rochester, New York 14642
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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3451 Walnut St
Philadelphia, Pennsylvania 19104
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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University of Arizona The University of Arizona is a premier, public research university. Established in...
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