A Data Collection Protocol to Evaluate the Real World Usa... | NCT07286357

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

NCT07286357

Sponsor

Orthofix Inc.

Status

Active, not recruiting

Last Update Posted

Dec 29, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Metatarsal Fracture

Interventions

AccelStim (LIPUS)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Dec 3, 2025

First Submission Date that Met QC Criteria

Dec 3, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2025

Last Update Posted Date

Dec 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AccelStim (LIPUS)		This group will include subjects where AccelStimStim (LIPUS) is used to treat fresh metatarsal fracture	Device: AccelStim (LIPUS)
Control (no LIPUS device)		This group will include subjects where AccelStimStim (LIPUS) was not used to treat fresh metatarsal fracture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	AccelStim (LIPUS)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern		Evanston	Illinois	60208	United States
Endeavor Health

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided