Clinical trial NCT02688855: CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bimalleolar Ankle Fractures
Keywords: Bone Growth Stimulator
Ankle Fracture
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 217
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change overtime of Olerud and Molander Ankle Score (OMAS)
timeFrame: 6 weeks, 8 weeks, 10 weeks and 12 weeks
measure: Non-powered, composite safety endpoint consisting of: Joint Position Outcome Radiographic Failure and Repeat, Unplanned Surgery at the Operative Site and Device-Related Serious Adverse Events
timeFrame: 6 months & 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Hollywood
country: United States
facility: Orthopaedic Associates of South Broward, P.A.
state: Florida
city: Orlando
country: United States
facility: OrlandoHealth
state: Florida
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Newark
country: United States
facility: Rutgers Biomedical Health Sciences
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: Phillips WA, Schwartz HS, Keller CS, Woodward HR, Rudd WS, Spiegel PG, Laros GS. A prospective, randomized study of the management of severe ankle fractures. J Bone Joint Surg Am. 1985 Jan;67(1):67-78.
citation: Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.