CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Last updated: March 18, 2022
Sponsor: Encore Medical, L.P.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02688855
PS-607
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Subject is diagnosed with an unstable, closed, isolated fracture of the ankle andunderwent operative stabilization with plate(s) and/or screws (Weber Ankle FractureClassification B and C)

Exclusion

Exclusion Criteria:

  • Subject has an open fracture
  • Subject has any additional fractures of another bone besides the ankle fracture thatis 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 fusionof the ankle joint
  • Malreduced Ankle as described by Phillips, et al 1985 JBJS
  • Surgical procedure included the use of osteoinductive materials in addition to rigidfixation
  • BMI ≥ 40 kg/m2

Study Design

Total Participants: 217
Study Start date:
January 23, 2017
Estimated Completion Date:
June 30, 2022

Connect with a study center

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90069
    United States

    Active - Recruiting

  • Orthopaedic Associates of South Broward, P.A.

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • OrlandoHealth

    Orlando, Florida 32828
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Rutgers Biomedical Health Sciences

    Newark, New Jersey 07103
    United States

    Active - Recruiting

  • University of Rochester

    Rochester, New York 14627
    United States

    Active - Recruiting

  • OhioHealth

    Westerville, Ohio 43082
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

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