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

N/AActive Not RecruitingNCT07286357

Orthofix Inc.100 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Northwestern

Evanston, Illinois, United States

Endeavor Health

Mount Prospect, Illinois, United States

Precision Orthopedics

Laurel, Maryland, United States

Outcomes

Primary Outcomes

Healing Status

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

Time frame: 3, 6, and 12 month

Secondary Outcomes

Pain (NPRS) (0-100)

Numerical Pain Rating Scale (NPRS) (0-100, where 100 is maximum pain)

Time frame: Baseline, 3, 6, and 12 month

Data from ClinicalTrials.gov

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