CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
NCT ID: NCT02688855
Last Updated: 2022-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
217 participants
INTERVENTIONAL
2017-01-23
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
NCT04015167
Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
NCT02188836
Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture
NCT01757951
Treatment of Fifth Metatarsal Zone 3 Fractures
NCT04847115
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures
NCT00429585
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Investigational Group
Standard Rigid Fixation + Active OL1000 device
Active Combined Magnetic Field OL1000 Bone Growth Stimulator
Active CMF OL1000 Device
Control Group
Standard Rigid Fixation + Sham OL1000 device
Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
Sham CMF OL1000
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active Combined Magnetic Field OL1000 Bone Growth Stimulator
Active CMF OL1000 Device
Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
Sham CMF OL1000
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
21 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Encore Medical, L.P.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Orthopaedic Associates of South Broward, P.A.
Hollywood, Florida, United States
OrlandoHealth
Orlando, Florida, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Rutgers Biomedical Health Sciences
Newark, New Jersey, United States
University of Rochester
Rochester, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PS-607
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.