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Rotator Cuff Repair Study
Thank you for participating in the Orthofix Rotator Cuff Repair Study. This
study is being conducted to determine if the RCStim device can improve the
healing of medium to full thickness tear rotator cuff injuries after muscle
repair.
The RCStim device has not been approved by the FDA for use in patients who
have undergone rotator cuff repair and its use is considered investigational.
The device used in this study is designed to be centered over the treatment
area so that your rotator cuff muscles will receive an adequate amount of
electromagnetic field generated by the RCStim device. The device comes in
either a right shoulder or a left shoulder model.
Your doctor should have instructed you to use the device for 90 minutes
each day for 6 months. It is very important that you use the RCStim device
each day as your doctor has directed. If you do not use the device correctly,
we may not be able to determine the effects of the treatment on rotator cuff
repair surgery healing.
If you have any questions regarding your device, please contact your doctor’s
office for assistance.
We sincerely thank you for your participation in the Orthofix Rotator Cuff
Repair study.
