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NCT Number: NCT07286357

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metatarsal Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern, Evanston, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AccelStim (LIPUS)

Device

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.

Other names: Low Intensity Pulsed UltraSound

Primary outcomes

  1. Healing Status

    Time frame: 3, 6, and 12 month

    Quantitative and qualitative assessments of clinical and radiographic healing (as available per standard of care)

Secondary outcomes

  1. Pain (NPRS) (0-100)

    Time frame: Baseline, 3, 6, and 12 month

    Numerical Pain Rating Scale (NPRS) (0-100, where 100 is maximum pain)

Sponsors and collaborators

Lead sponsor

Orthofix Inc.

Industry

Registry information

Official study title

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

Acronym: ASRW

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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