Metatarsal FractureASRWNCT07286357
A Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures
An observational study of Metatarsal Fracture, run by Orthofix Inc. at 3 sites in United States.
Trial summary
This study examines the effect of using the AccelStim bone growth stimulator on subjects undergoing treatment for fresh metatarsal fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metatarsal Fracture
- What is being tested?
- AccelStim (LIPUS)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 May 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Fresh metatarsal fracture patient that has been prescribed an Orthofix AccelStim device
- Patient is 18 years or older at the time of treatment
Who cannot join
- -Patient is a prisoner
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern
Evanston, Illinois, 60208
Precision Orthopedics
Laurel, Maryland, 20707
Endeavor Health
Mount Prospect, Illinois, 60056
About this study
Official title: 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.
Read the 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.
- Conditions
- Metatarsal Fracture
- Being tested
- AccelStim (LIPUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelStim (LIPUS)Device
Also called Low Intensity Pulsed UltraSound
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.
| Study group | Role | What they receive |
|---|---|---|
| AccelStim (LIPUS) | This group will include subjects where AccelStimStim (LIPUS) is used to treat fresh metatarsal fracture Receives: Device: AccelStim (LIPUS) | |
| Control (no LIPUS device) | This group will include subjects where AccelStimStim (LIPUS) was not used to treat fresh metatarsal fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Status
Quantitative and qualitative assessments of clinical and radiographic healing (as available per standard of care)
Measured: 3, 6, and 12 month
Secondary outcomes (1)
Pain (NPRS) (0-100)
Numerical Pain Rating Scale (NPRS) (0-100, where 100 is maximum pain)
Measured: Baseline, 3, 6, and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start30 May 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metatarsal FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286357
- Sponsor's protocol ID
- CIP-ASRW-24
- Acronym
- ASRW
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Retrospective Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures
- ClinicalTrials.gov ID
- NCT07286357
- Acronym / sponsor ID
- ASRW / CIP-ASRW-24
- Conditions
- Metatarsal Fracture
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AccelStim (LIPUS) | – | Device: AccelStim (LIPUS)This group will include subjects where AccelStimStim (LIPUS) is used to treat fresh metatarsal fracture |
| Control (no LIPUS device) | – | –This group will include subjects where AccelStimStim (LIPUS) was not used to treat fresh metatarsal fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Fresh metatarsal fracture patient that has been prescribed an Orthofix AccelStim device
- Patient is 18 years or older at the time of treatment
Key exclusion criteria (1 listed)
- -Patient is a prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelStim (LIPUS)Also: Low Intensity Pulsed UltraSoundSubjects treated with LIPUS were directed to use the AccelStim device for 20 minutes per day, up to 6 months or until no longer needed. | Device | AccelStim (LIPUS) |
Primary outcome
Healing Status
Time frame: 3, 6, and 12 month
Quantitative and qualitative assessments of clinical and radiographic healing (as available per standard of care)
1 secondary outcome
Pain (NPRS) (0-100)
Time frame: Baseline, 3, 6, and 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metatarsal Fracture, run by Orthofix Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Status (time frame: 3, 6, and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.