CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Not Applicable

• Conditions: Bimalleolar Ankle Fractures
• Interventions: Device: Active Combined Magnetic Field OL1000 Bone Growth Stimulator; Device: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator

• Registration Number: NCT02688855
• Lead Sponsor: Encore Medical, L.P.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Study Start: 2017-01-23
• Status Verified: 2021-12
• Primary Completion: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 217

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Group	Active Combined Magnetic Field OL1000 Bone Growth Stimulator	Standard Rigid Fixation + Active OL1000 device
Control Group	Sham Combined Magnetic Field OL1000 Bone Growth Stimulator	Standard Rigid Fixation + Sham OL1000 device

Primary Outcome Measures

Name	Time	Method
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	6 months & 12 months
Change overtime of Olerud and Molander Ankle Score (OMAS)	6 weeks, 8 weeks, 10 weeks and 12 weeks

Trial Locations

Locations (9)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Orthopaedic Associates of South Broward, P.A.; 🇺🇸 Hollywood, Florida, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Rutgers Biomedical Health Sciences; 🇺🇸 Newark, New Jersey, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

OrlandoHealth; 🇺🇸 Orlando, Florida, United States