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Recovery Force MAC Device


Title Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
Therapeutic Area Joint Disorders
Principal Investigator Matthew Salzer, MD
Min Age 40 Years
Max Age 85 Years
Gender Any
Contact Nicole Gauthier
617-636-5159
ngauthier1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04995601

Overview

This is an NIH-funded clinical trial investigating ease of use and patient compliance with an alternative Intermittent Pneumatic Compression (IPC) device created by Recovery Force. This new product, the Recovery Force Movement and Compression (MAC) device, is a walking boot that is designed to increase mobility after a total joint replacement surgery, while also decreasing the risk of Deep Vein Thrombosis (DVT). Subjects will be randomly assigned either the standard of care IPC device or the Recovery Force MAC system. If randomly assigned the Recovery Force MAC device, subjects will wear the device home and return it at their two week post-operative appointment with their surgeon. Subjects will complete four separate 4-meter walk tests before and after surgery to track their mobility. Subjects will also record their mobility daily during their two-week post-operative period, using the provided mobility tracker and journals. This study has many goals, but one is to test how comfortable and easy to use this device is. This will be tested by a series of studies once the subject has returned the device.

Study Details

Inclusion Criteria

  • Adult subjects ages 40-85 who are having their firs elective total hip replacement, or first or second (opposite knee) elective total knee replacement
  • English-speaking
  • BMI between 18-39

Exclusion Criteria

  • Subjects that require a partial joint replacement or any total joint replacement (TJR) revision surgery
  • Subjects who are non-ambulatory or are unable to perform self-care
  • Subjects with a calf deformity or with a calf circumference greater than 24.5 inches

Study Requirements

2 clinic visit (pre-operative and post-operative appointments), four 4-meter walk tests in the outpatient Orthopaedic clinic and during the overnight stay after surgery, journaling and self-monitoring mobility progress, using and recording data from a mobility tracker, using and recording data from the investigational boot, the Recovery Force MAC system. At the end of the post-operative period, subjects will complete a survey about their experience using the device, whether it was comfortable or easy to use.