Global Spine Implant Quality
In some countries, regulatory organizations exist to help evaluate quality (e.g., the United States has the FDA). However, in other countries, gaps in regulation exist. This issue arose during our project looking at implant access, inspired by Kelly’s story about sourcing implants for her spine surgery. We found in looking at issues of implant access, good quality information about implant quality may be lacking to help patients when they purchase their own implants for surgery. Enuval’s goal is to address this gap in information about quality by testing the strength of screw and rod combinations sourced globally and then making this information available to patients and their surgeons.
These are implants used in spine surgery embedded in plastic blocks for testing in protocols that mimic their function in the spine. These particular implants show different failure mechanisms (rod fracture, screw head disengagement).
While regulatory organizations exist in some countries to help standardize evaluate spine implant quality, this is not the case across the world. Unbiased information about global implant quality is scarce. In the United States, pedicle screws are approved for use through a standard process - the FDA establishes that a new pedicle screw type is equivalent to a pre-existing implant, and the implant company submits additional information about its product to the FDA for evaluation. Key in this package of information is testing data where implants are exposed to a standard load that mimics what they might experience (or more than they would experience) in the human body. This information is not usually publicly available.
In many countries outside of the United States and Europe, standard regulation does not exist. Thus, not only information about the strength of implants is not publicly available, there is limited regulatory oversight. This means that in cases where patients have to purchase their own implants, the only distinguishing information they have is the price of the screw.
Enuval is working to change this by testing implants used in countries where our members reside and making this data publicly available. We are in the process of building out our testing database, and plan to make soon this data open access to all.
This research is currently supported by the AO NA Spine Foundation and made possible by a partnership with the Surgical Implant Generation Network (SIGN) and Instron.
Preparing implant constructs for mechanical testing.