Have Questions? We have answers..
Who can participate? Any spine surgeon or spine group may participate in the Registry. You must be able to use the Innovasis HA PEEK products and have the staff to upload the data into the program.
Is there a cost to participate? There may be some cost to participate depending on IRB fees. There are no need for additional equipment. You will need to designate a person on your staff to upload the data. Innovasis will underwrite staffing resources needed to administer the registry. There should be no extra cost to the patient as the follow up visits should be consistent with surgical follow up standard of care.
How do I input the patients data? The registry is run on a secure web based portal called Unity. Patients may use a tablet, provided by Innovasis, to take Patient Reported Outcome Measures(PROMS) and are electronically stored on a secure server. A member of your staff will be responsible for uploading radiographic images and clinical report forms using the same website.
What is the Impact of the database? The database will allow users to track PROMS and fusion rates of patients receiving HA PEEK devices.
WIll I have access to outcomes from other patients in the registry? Participating sites will have access to their own patients data on an individual and aggregate level. Sites will also have access to the data on an aggregate level (entire population).
Is the patients data secure? Our program anonymizes PROMS and Radiographs so that data cannot be tracked back to the patient. The data base is HIPAA compliant.