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CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

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ClinicalTrials.gov Identifier: NCT02688855
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bimalleolar Ankle Fractures Device: Active Combined Magnetic Field OL1000 Bone Growth Stimulator Device: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational Group
Standard Rigid Fixation + Active OL1000 device
Device: Active Combined Magnetic Field OL1000 Bone Growth Stimulator
Active CMF OL1000 Device
Other Name: CMF OL1000

Sham Comparator: Control Group
Standard Rigid Fixation + Sham OL1000 device
Device: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
Sham CMF OL1000
Other Name: CMF OL1000




Primary Outcome Measures :
  1. Change overtime of Olerud and Molander Ankle Score (OMAS) [ Time Frame: 6 weeks, 8 weeks, 10 weeks and 12 weeks ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688855


Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Daniel Latt, MD    520-626-5472    mgordon@email.arizona.edu   
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90069
Contact: Charles Moon, MD    310-423-1620    Goran.Stankovic@cshs.org   
United States, Florida
Orthopaedic Associates of South Broward, P.A. Recruiting
Hollywood, Florida, United States, 33021
Contact: Steven Steinlauf, MD    954-854-3463    info@oasb.net   
OrlandoHealth Recruiting
Orlando, Florida, United States, 32828
Contact: Kenneth Koval, MD    321-841-3867    Paula.Harriott@orlandohealth.com   
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Zachary Vaupel, MD    248-551-0194    Kelly.Slade@beaumont.org   
United States, New Jersey
Rutgers Biomedical Health Sciences Recruiting
Newark, New Jersey, United States, 07103
Contact: Sheldon Lin, MD    973-972-2184    emo65@njms.rutgers.edu   
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14627
Contact: Kyle Judd, MD    585-276-7790    Kyle_Judd@URMC.Rochester.edu   
United States, Ohio
OhioHealth Recruiting
Westerville, Ohio, United States, 43082
Contact: Gregory Berlet, MD    614-895-8747    ofacresearch@orthofootankle.com   
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Daniel Farber, MD    215-829-3613    Aliaksei.Basatski@uphs.upenn.edu   
Sponsors and Collaborators
Encore Medical, L.P.

Additional Information:
Publications of Results:
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Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT02688855     History of Changes
Other Study ID Numbers: PS-607
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Encore Medical, L.P.:
Bone Growth Stimulator
Ankle Fracture

Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries