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

Orthofix

Status: Active, not recruiting

Conditions: Metatarsal Fracture

Treatments: Device: AccelStim (LIPUS)

Study type: Observational

Funder types: Industry

Identifiers

NCT07286357

CIP-ASRW-24

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

AccelStim (LIPUS)

Description:

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

Treatment:

Device: AccelStim (LIPUS)

Control (no LIPUS device)

Description:

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