Recruiting

CMF Bone StimulationCMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Sponsor:

Encore Medical, L.P.

Code:

NCT02688855

Conditions

Bimalleolar Ankle Fractures

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Active Combined Magnetic Field OL1000 Bone Growth Stimulator

Sham Combined Magnetic Field OL1000 Bone Growth Stimulator

Study Details

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.

Conditions

Bimalleolar Ankle Fractures

Study ID

NCT02688855

Start date

Jan 23, 2017

Status verified date

Dec, 2021

Completion date

Jun, 2022

Anticipated

Primary completion date

Mar, 2022

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

217 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Investigational Group

Standard Rigid Fixation + Active OL1000 device

sham comparator: Control Group

Standard Rigid Fixation + Sham OL1000 device

Interventions

Active Combined Magnetic Field OL1000 Bone Growth Stimulator

Active CMF OL1000 Device

Sham Combined Magnetic Field OL1000 Bone Growth Stimulator

Sham CMF OL1000

Primary outcome measure

Change overtime of Olerud and Molander Ankle Score (OMAS) [ Time Frame: 6 weeks, 8 weeks, 10 weeks and 12 weeks ]
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 [ Time Frame: 6 months & 12 months ]

Central Contacts and Locations

Central contacts

Akujuobi Udu, MS

248-914-0150 akujuobi.udu@djoglobal.com

Jessica Knowlton, MS

732-666-7550 jessica.knowlton@djoglobal.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Daniel Latt, MD

520-626-5472 mgordon@email.arizona.edu

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90069

Contacts

Charles Moon, MD

310-423-1620 Goran.Stankovic@cshs.org

Orthopaedic Associates of South Broward, P.A.

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Steven Steinlauf, MD

954-854-3463 info@oasb.net

William Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Zachary Vaupel, MD

248-551-0194 Kelly.Slade@beaumont.org

Rutgers Biomedical Health Sciences

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Sheldon Lin, MD

973-972-2184 emo65@njms.rutgers.edu

University of Rochester

Recruiting

Rochester, New York, United States, 14627

Contacts

Kyle Judd, MD

585-276-7790 Kyle_Judd@URMC.Rochester.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Daniel Farber, MD

215-829-3613 Aliaksei.Basatski@uphs.upenn.edu

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Minton Cooper, MD

434-243-0256 MTC2D@hscmail.mcc.virginia.edu

Principal Investigator:

Minton Cooper, MD

More Information

Sponsor

Encore Medical, L.P.

Last update posted

Mar 21, 2022

Last verified

Dec, 2021

Keywords

Bone Growth Stimulator
Ankle Fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Encore Medical, L.P. on 2022-03-21.