FDA Clears a Smart Robotic External Fixation Device
A 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).
The external fixation method is the most common option for the treatment of orthopedic problems such as complex fractures and bone 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.
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.