CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

March 18, 2022 updated by: Encore Medical, L.P.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

217

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • Los Angeles, California, United States, 90069
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Orthopaedic Associates of South Broward, P.A.
        • Contact:
          • Steven Steinlauf, MD
          • Phone Number: 954-854-3463
          • Email: info@oasb.net
      • Orlando, Florida, United States, 32828
        • Withdrawn
        • OrlandoHealth
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • William Beaumont Hospital
        • Contact:
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers Biomedical Health Sciences
        • Contact:
    • New York
      • Rochester, New York, United States, 14627
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Minton Cooper, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CMF OL1000

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Encore Medical, L.P.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 23, 2017

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (ESTIMATE)

February 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS-607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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