CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
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
1 other identifier
interventional
217
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedStudy Start
First participant enrolled
January 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedMarch 21, 2022
December 1, 2021
5.1 years
February 18, 2016
March 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change overtime of Olerud and Molander Ankle Score (OMAS)
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
6 months & 12 months
Study Arms (2)
Investigational Group
EXPERIMENTALStandard Rigid Fixation + Active OL1000 device
Control Group
SHAM COMPARATORStandard Rigid Fixation + Sham OL1000 device
Interventions
Active CMF OL1000 Device
Sham CMF OL1000
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Arizona
Tucson, Arizona, 85724, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90069, United States
Orthopaedic Associates of South Broward, P.A.
Hollywood, Florida, 33021, United States
OrlandoHealth
Orlando, Florida, 32828, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Rutgers Biomedical Health Sciences
Newark, New Jersey, 07103, United States
University of Rochester
Rochester, New York, 14627, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (2)
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.
PMID: 3881447RESULTOlerud 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.
PMID: 6437370RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2016
First Posted
February 23, 2016
Study Start
January 23, 2017
Primary Completion
March 1, 2022
Study Completion
June 1, 2022
Last Updated
March 21, 2022
Record last verified: 2021-12