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CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

Primary Purpose

Bimalleolar Ankle Fractures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Combined Magnetic Field OL1000 Bone Growth Stimulator
Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
Sponsored by
Encore Medical, L.P.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bimalleolar Ankle Fractures focused on measuring Bone Growth Stimulator, Ankle Fracture

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of ArizonaRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • Orthopaedic Associates of South Broward, P.A.Recruiting
  • OrlandoHealth
  • William Beaumont HospitalRecruiting
  • Rutgers Biomedical Health SciencesRecruiting
  • University of RochesterRecruiting
  • University of PennsylvaniaRecruiting
  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Investigational Group

Control Group

Arm Description

Standard Rigid Fixation + Active OL1000 device

Standard Rigid Fixation + Sham OL1000 device

Outcomes

Primary Outcome Measures

Change overtime of Olerud and Molander Ankle Score (OMAS)
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

Secondary Outcome Measures

Full Information

First Posted
February 18, 2016
Last Updated
March 18, 2022
Sponsor
Encore Medical, L.P.
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1. Study Identification

Unique Protocol Identification Number
NCT02688855
Brief Title
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Medical, L.P.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bimalleolar Ankle Fractures
Keywords
Bone Growth Stimulator, Ankle Fracture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Group
Arm Type
Experimental
Arm Description
Standard Rigid Fixation + Active OL1000 device
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Standard Rigid Fixation + Sham OL1000 device
Intervention Type
Device
Intervention Name(s)
Active Combined Magnetic Field OL1000 Bone Growth Stimulator
Other Intervention Name(s)
CMF OL1000
Intervention Description
Active CMF OL1000 Device
Intervention Type
Device
Intervention Name(s)
Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
Other Intervention Name(s)
CMF OL1000
Intervention Description
Sham CMF OL1000
Primary Outcome Measure Information:
Title
Change overtime of Olerud and Molander Ankle Score (OMAS)
Time Frame
6 weeks, 8 weeks, 10 weeks and 12 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akujuobi Udu, MS
Phone
248-914-0150
Email
akujuobi.udu@djoglobal.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Knowlton, MS
Phone
732-666-7550
Email
jessica.knowlton@djoglobal.com
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Latt, MD
Phone
520-626-5472
Email
mgordon@email.arizona.edu
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Moon, MD
Phone
310-423-1620
Email
Goran.Stankovic@cshs.org
Facility Name
Orthopaedic Associates of South Broward, P.A.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Steinlauf, MD
Phone
954-854-3463
Email
info@oasb.net
Facility Name
OrlandoHealth
City
Orlando
State/Province
Florida
ZIP/Postal Code
32828
Country
United States
Individual Site Status
Withdrawn
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Vaupel, MD
Phone
248-551-0194
Email
Kelly.Slade@beaumont.org
Facility Name
Rutgers Biomedical Health Sciences
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheldon Lin, MD
Phone
973-972-2184
Email
emo65@njms.rutgers.edu
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Judd, MD
Phone
585-276-7790
Email
Kyle_Judd@URMC.Rochester.edu
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Farber, MD
Phone
215-829-3613
Email
Aliaksei.Basatski@uphs.upenn.edu
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minton Cooper, MD
Phone
434-243-0256
Email
MTC2D@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Minton Cooper, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
3881447
Citation
Phillips WA, Schwartz HS, Keller CS, Woodward HR, Rudd WS, Spiegel PG, Laros GS. A prospective, randomized study of the management of severe ankle fractures. J Bone Joint Surg Am. 1985 Jan;67(1):67-78.
Results Reference
result
PubMed Identifier
6437370
Citation
Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.
Results Reference
result
Links:
URL
http://www.djoglobal.com/products/cmf/cmf-ol1000
Description
Related Info

Learn more about this trial

CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

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