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

December 22, 2025 updated by: Orthofix Inc.

A Multi-Center Retrospective 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern
      • Mount Prospect, Illinois, United States, 60056
        • Endeavor Health
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Precision Orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AccelStim (LIPUS)
This group will include subjects where AccelStimStim (LIPUS) is used to treat fresh metatarsal fracture
Device: AccelStim (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.
Other Names:
  • Low Intensity Pulsed UltraSound
Control (no LIPUS device)
This group will include subjects where AccelStimStim (LIPUS) was not used to treat fresh metatarsal fracture

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthofix Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Estimated)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CIP-ASRW-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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