NCT07286357

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
May 2025Jun 2026

Study Start

First participant enrolled

May 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 3, 2025

Last Update Submit

December 22, 2025

Conditions

Metatarsal Fracture

Outcome Measures

Primary Outcomes (1)

  • Healing Status

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

    3, 6, and 12 month

Secondary Outcomes (1)

  • Pain (NPRS) (0-100)

    Baseline, 3, 6, and 12 month

Study Arms (2)

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

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.

Also known as: Low Intensity Pulsed UltraSound
AccelStim (LIPUS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patient is a prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northwestern

Evanston, Illinois, 60208, United States

Location

Endeavor Health

Mount Prospect, Illinois, 60056, United States

Location

Precision Orthopedics

Laurel, Maryland, 20707, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 16, 2025

Study Start

May 30, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)