Frequently Asked Questions for Professionals
This FAQ page is intended for physicians to provide information about OrthoTin TMJ implants. It includes details about manufacturing time, design processes, patient models and complications as well as additional information that is needed to help you make the most informed decision about using our implants.
How long does it take to make a set of OrthoTiN TMJ implants?
OrthoTiN standard manufacturing time is 10 business days. This means that from the surgeon’s design approval, OrthoTiN can ship the implants to the customer on the 10 business days from the date of the approval.
How long does the design process take for OrthoTiN TMJ implants?
There are a few stages of the design process. Typically, from the receiving patient data, proposed design is generated and provided virtually to the surgeon for review, feedback and approval. If there is no further input from the surgeon, design can be finalized within 48 hours and the manufacturing process can be started. If further input is provided from the surgeon, the design process will take a longer depending on the surgeon input turnaround.
Does OrthoTiN provide virtual surgical planning?
OrthoTiN has relationships with virtual planning services and can provide virtual surgical planning through one of our vendors or can directly work with the surgeon if surgeon prefers to work with VSP service of his choice.
Where should I send patient scan and occlusion data for the virtual planning service?
Please send it directly to the OrthoTiN upload platform for review and next step.
What screws do I use for the fossa and mandible?
2.0mm screws are the standard on both the fossa and mandible with 2.3mm screws acting as the backup screw. OrthoTiN offers 2.0mm screws in 5mm to 16mm lengths and 2.3mm screws in 6mm to 16mm lengths. Every case has screw lengths measured at the time of final evaluation just prior to cleaning and packaging. Photos with recommended screw lengths are provided with every case for reference. Note: subtle variations in placement of the implant components and drill angle may require different screw lengths.
Will I have the patient model in surgery for reference?
Every case is shipped to your hospital with the non-sterile model that was used for the case, unless you have made prior arrangements to have the model shipped to your office. Make sure to have it available at surgery for reference. The non-sterile model can often be essential to assure the components are placed as planned.
Can I sterilize the model?
No, the model may warp, or distort.
What do I do if my patient says they have material sensitivity to one or more of the implant materials?
There is little consensus on how to evaluate and manage patients reporting a possible material sensitivity to joint replacement devices containing metal. The specific material composition of the OrthoTiN implant components can be found elsewhere on our webpage. There are 2 tests that can be used to evaluate patients for hypersensitivity: skin patch testing (SPT) and the lymphocyte transformation test (LTT). However, there is no agreement on the best timing and under what clinical circumstances a patient should undergo a hypersensitivity workup. The skin patch test has not been shown to be a reliable indicator of metal implant hypersensitivity. Before a primary total joint replacement, testing can be helpful when a patient reports a history of intolerance to jewelry or of an allergic reaction to a prior metal implant. However, to date, routine testing is not supported by the literature. Currently, the diagnosis of hypersensitivity to metal implants appears to be one of exclusion and there are no available clear-cut management algorithms. Based on a review of the available orthopedic literature, a practical workup and management of potential material hypersensitivity algorithm for pre and post op patients was developed. (see, Mercuri LG, Caicedo MS. Material Hypersensitivity and TMJ Replacement. J Oral Maxillofac Surg 77:1371-1376, 2019.) OrthoTiN is only able to provide a limited quantity of all-titanium mandibular implants via the FDA’s compassionate use program for documented highly reactive material sensitive patients. Please consult with us regarding ordering All-Ti implants for details on this process
Can a bilateral patient have material sensitivity on just one side?
Yes, as contrary as it seems, patients suspected of material sensitivity are often displaying symptoms on just one side. The reason for this is not understood.
What is the frequency of infections with OrthoTiN devices?
Infection is the most common complication, but the risk is low: 2 to 3%. Infections can develop at the time of surgery, or sometimes even many years later. There is no absolute test for the preoperative diagnosis of periprosthetic joint infection (PJI); thus, clinical practice relies on a combination of supportive tests and criteria. (Mercuri LG. Temporomandibular Joint Replacement Periprosthetic Joint Infections: A Review of Early Diagnostic Testing Options. Int J Oral Maxillofac Surg 43:1236–1242, 2014.)
When executing a combined TMJ replacement and maxillary orthognathic surgery case, should the TMJ replacement be performed first or the maxilla?
TMJ replacement should always be performed first in combined maxillary and OrthoTiN cases. If the maxilla is performed first, and not positioned in the exact pre-surgically designed position, the custom OrthoTiN components may not interface properly with the host bone nor articulate appropriately.
Are cone beam CT (CBCT) scans OK to use for fabrication of the stereolithic model from which the OrthoTiN TMJ implant components are designed and manufactured?
While a medical grade CT scan is preferred and provides higher quality resolution, CBCT scans can often be used. However, CBCT scans emit much less radiation and therefore have a harder time penetrating anatomy. This can be problematic when there is hardware in place such as metal plates, implants, etc. CBCT scans have different quality levels, so it is important that the highest resolution scan is used. If there is a CBCT scan that is already available, please send it to OrthoTiN for evaluation to assure it will provide the proper quality for the design and manufacturing processes.
What happens if my patient has complications that contraindicate proceeding with the surgery or decides not to go ahead with the surgery during the manufacturing process, or after the implants have been made?
OrthoTiN does not initiate the manufacturing process for devices until a purchase order from the hospital is in place. Since OrthoTiN implants are custom, they are not returnable. Partially completed implants will be billed based upon the level of completion. Full payment against the issued purchase order will be expected for all implants that have been shipped. If your hospital has concerns with this policy, please suggest that the hospital request a deposit from the patient for the cost of the implants before the hospital issues a purchase order. If implants are in-process when cancellation occurs, partial charges may be incurred.
Are the implants returnable if the patient does not have the surgery?
OrthoTiN implants are custom-made and are not returnable. Once shipped, full payment will be expected against the issued purchase order.
If I decide to do a staged procedure, what can I do to reduce the time between the first and second-stage surgeries?
Be sure to notify OrthoTiN well before your first-stage surgery, so we have the opportunity to discuss with you the specifics of your case and a potential first-stage surgery date. Sending in an order form weeks in advance of your first stage will allow us to reserve a place in our production queue, and also allows us to start talking to your hospital about a purchase order. Staged cases always take priority whether for ankylosis or implant revision. Such cases typically can be completed within 6 weeks. The axiom with such cases should always be to get as much done as possible in stage one to make stage two easier. Thorough debridement of the surgical site, recontouring or remodeling of heterotopic bone, then establishing the desired post-op occlusion for the protocol scan will assure that we can proceed straight to implant design once the post stage one imaging arrives. As some of these staged cases can be quite complex, our clinical consultants are always happy to review pre-staged imaging and make recommendations regarding goals for the first-stage surgery. We can accommodate full virtual surgical planning for these cases should you wish cutting guide(s) or occlusal splint(s).