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FDA Clears a Smart Robotic External Fixation Device

Daniel Marcus';

By Daniel Marcus

Posted on October 31st, 2019 in Marina Robotics

Open Heart Surgery in Multivessel DiseaseA smart robotic external fixation system developed for orthopedic treatment by OrthoSpin Ltd., a portfolio company of The Trendlines Group Ltd., has received the regulatory clearance from the United States Food and Drug Administration (FDA).

External fixation devices are hardware used to hold broken bones together by using transfixing metal pins through the fragments and a compression device attached to the pins outside the skin surface. The external fixator looks and acts like a stabilizing frame, supporting the unstable bone following surgery.

The fixator gradually lengthens the limb through mechanical stimulation by pulling the segments of bone apart. However, these manual adjustments are problematic, and if not done correctly the patient can suffer pain and even repeat surgeries.

External Fixation Device - an Overview

An external fixator is a valuable instrument for fracture reduction and certain difficult orthopedic problems such as:

  • bone lengthening
  • setting complex fractures
  • correcting deformities

Lack of patient compliance and real-time feedback for the doctor are the two major challenges associated with the external fixation system.

With this system, the patients need to perform various manual adjustments each day that may lead to errors. Therefore, this would require significant training of the patients as well as their involvement.

Most of the time, patients fail to comply with the mechanical adjustments precisely because of which clinical outcomes are poor.

The OrthoSpin system allows for objective measurement, ease of use, and delivers a better patient experience. Integrated software enables physicians to chart patient progress remotely and, if necessary, immediately adjust the treatment regimen. Founded in 2014, OrthoSpin set itself the goal of introducing the first advance in the trauma market for external fixation in the past 20 years.

Features of the Robotic External Fixation System

The robotic external fixation device helps overcome the challenges faced during the use of manual fixation devices in orthopedic treatment. The three main features of the smart robotic system include:

  • The system makes automatic adjustments that are pre-programmed and thus eliminates the need for patient training and manual adjustments.
  • It gives a better experience to patients as it is less painful and reduces the need for time-consuming follow-ups.
  • Monitoring of biomechanical parameters and in the future, the device would be able to send real-time updates to doctors to follow the patient’s progress. This will allow fine-tuning of the treatment regimen and development of a personalized treatment plan for every patient.

The first-in-human case for the robotic external fixation system was a 15-year old patient with a deformity of the tibia. The deformity resulted in leg shortening and a limp, which restricted his daily activities and also had the potential to disrupt his growth. Surgery was performed to correct the deformity following which external fixation was done with OrthoSpin’s smart automatic control system.

This system can potentially change the outcomes of several orthopedic treatments including fracture fixation, non-unions, correction of bony or soft tissue deformities, and limb lengthening. Moreover, the system allows objective measurement and provides peace of mind to the patients and their families due to its ease of use.

Cedars Sinai Marina del Rey Hospital Offers Some of the Finest Orthopedic Care in the Region

If you are seeking treatment for a fracture, request an appointment with one of our specialists today. With a focus on the care and comfort of each patient, the orthopedic physicians at our hospital can tell you if treatment with the orthopedic external fixation device is right for you, and what to expect from the external fixation of your fracture. At Cedars Sinai Marina del Rey Hospital, you have access to comprehensive orthotic and prosthetic services that meet your individual needs.