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

NCT ID: NCT07286357

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-30

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Metatarsal Fracture

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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AccelStim (LIPUS)

This group will include subjects where AccelStimStim (LIPUS) is used to treat fresh metatarsal fracture

AccelStim (LIPUS)

Intervention Type 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.

Control (no LIPUS device)

This group will include subjects where AccelStimStim (LIPUS) was not used to treat fresh metatarsal fracture

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Low Intensity Pulsed UltraSound

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthofix Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northwestern

Evanston, Illinois, United States

Site Status

Endeavor Health

Mount Prospect, Illinois, United States

Site Status

Precision Orthopedics

Laurel, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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CIP-ASRW-24

Identifier Type: -

Identifier Source: org_study_id