A Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures

A Multi-Center Retrospective Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07286357

Acronym

ASRW

Enrollment

100

Registered

2025-12-16

Start date

2025-05-30

Completion date

2026-06-30

Last updated

2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metatarsal Fracture

Brief summary

This study examines the effect of using the AccelStim bone growth stimulator on subjects undergoing treatment for fresh metatarsal fractures.

Detailed description

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.

Interventions

DEVICEAccelStim (LIPUS)

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.

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Fresh metatarsal fracture patient that has been prescribed an Orthofix AccelStim device * Patient is 18 years or older at the time of treatment

Exclusion criteria

-Patient is a prisoner

Design outcomes

Primary

Measure	Time frame	Description
Healing Status	3, 6, and 12 month	Quantitative and qualitative assessments of clinical and radiographic healing (as available per standard of care)

Secondary

Measure	Time frame	Description
Pain (NPRS) (0-100)	Baseline, 3, 6, and 12 month	Numerical Pain Rating Scale (NPRS) (0-100, where 100 is maximum pain)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026