An observational study in Metatarsal Fracture, sponsored by Orthofix Inc.. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Orthofix Inc. · Observational
This study examines the effect of using the AccelStim bone growth stimulator on subjects undergoing treatment for fresh metatarsal fractures.
The objective of this investigation is to study the effect of using LIPUS treatment (via AccelStim) in subjects with fresh metatarsal fractures. The sponsor hypothesizes that use of AccelStim will result in higher rates of fusion compared to that of control. In addition to analyzing the primary endpoint, the study will collect safety information to confirm the favorable safety profile established in prior device usage.
Orthofix Inc. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who were treated for eligible fresh metatarsal fractures and were subsequently prescribed an Orthofix AccelStim device will be considered for participation in this retrospective study. Cases will be identified by searching local medical records and/or device prescription information received at Orthofix.
Exclusion Criteria:
-Patient is a prisoner
This group will include subjects where AccelStimStim (LIPUS) is used to treat fresh metatarsal fracture
Device: AccelStim (LIPUS)
This group will include subjects where AccelStimStim (LIPUS) was not used to treat fresh metatarsal fracture
Subjects treated with LIPUS were directed to use the AccelStim device for 20 minutes per day, up to 6 months or until no longer needed.
Also known as: Low Intensity Pulsed UltraSound
Healing Status
Quantitative and qualitative assessments of clinical and radiographic healing (as available per standard of care)
Time frame: 3, 6, and 12 month
Pain (NPRS) (0-100)
Numerical Pain Rating Scale (NPRS) (0-100, where 100 is maximum pain)
Time frame: Baseline, 3, 6, and 12 month
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Orthofix Inc.