One Patient, One Implant

If your knee is severely damaged by arthritis or injury, it may be hard for you to perform
simple activities, such as walking or climbing stairs. You may even begin to feel pain while
you are sitting or lying down.

The most common cause of chronic knee pain and disability is arthritis. Although there are
many types of arthritis, most knee pain is caused by just three types: osteoarthritis,
rheumatoid arthritis, and post-traumatic arthritis. If nonsurgical treatments like
medications and using walking supports are no longer helpful, you may want to consider
total knee replacement surgery. Joint replacement surgery featuring Conformis-supplied
technologies is a safe and effective procedure to relieve pain, correct leg deformity, and
help you resume normal activities.
Knee replacement surgery was first performed in 1968. Since then, improvements in
surgical materials and techniques have greatly increased its effectiveness. Total knee
replacements are one of the most successful procedures in all of medicine. According to the
Center for Disease Control and Prevention, more than 700,000 knee replacements are
performed each year in the United States.

A knee replacement (also called knee arthroplasty) might be more accurately termed a
knee "resurfacing" because only the surface of the bones is actually replaced.
There are four basic steps to a knee replacement procedure.

  • Prepare the bone. The damaged cartilage surfaces located at the ends of the femur and tibia are removed along with a small amount of underlying bone.
  • Position the metal implants. The removed cartilage and bone is replaced with metal components that recreate the surface of the joint. These metal parts may be cemented or "press-fit" into the bone.
  • Resurface the patella. The undersurface of the patella (kneecap) is cut and resurfaced with a plastic button. Some surgeons do not resurface the patella, depending upon the case.
  • Insert a spacer. A medical-grade plastic spacer is inserted between the metal components to create a smooth gliding surface.

If you need knee replacement surgery, consider customized knee replacement surgery.
Combining CT imaging, modeling software, and 3D printing technology, Conformis offers
implants tailored specifically to each patient. This advanced technology helps avoid
complications that often follow the procedure, such as pain due to the instability of the joint.
Issues can range from minor blood loss and infections to the threat of deep venous thrombosis.

Conformis, however, improves on traditional methods by advancing from generic, "off-the-
shelf" implants to a more customizable 3D-based solution. One of the most promising

applications of 3D printing in medical fields is the ability to produce patient-specific devices.

Conformis’ strategy in creating to 3D-printed implants includes:

  • Taking a CT scan of the patient's hip, knee, and ankle.
  • Converting the scan into an exact 3D model of the patient's deteriorating knee.
  • Using the 3D model to craft personalized implants and instruments as one-off devices, produced, in part, by 3D printers.

Empire Surgical Solutions, founded by Vincent Dugan, is an exclusive distributor for
Conformis, along with two other well-known distributors, NanoHealth USA and TriMed.
Empire Surgical Solutions seeks to improve the lives of surgeons and patients by providing
innovative orthopedic devices for their community.

Conformis, NanoHealth USA, and TriMed all utilize advanced joint replacement
technologies that offer such benefits as:

  • Individualized fit that reduces sizing compromises common with off-the-shelf implants and associated with residual pain after surgery. Following the shape and contour of each patient’s knee, providing an increased potential for a more natural-feeling knee.
  • Optimal bone preservation.
  • Reproducible surgical technique using disposable pre-navigated iJig® instrumentation and

iView surgical planning images with detailed resection values able to verify accuracy
throughout the surgery.


One-in-five patients are not satisfied with their traditional total knee replacement. In
traditional knee replacement surgery, the surgeon selects an “off-the-shelf” implant from a
range of standard fixed sizes, and then has to make the necessary adjustments to fit the
implant to the patient during the procedure.


Because off-the-shelf knee replacements aren’t designed for a patient’s specific anatomy,
surgeons must compromise on implant fit. This compromise may result in having implant
overhang (implant hanging over the bone) or underhang (a too-small implant leaves
leaving the bone exposed and uncovered). It could also result in an improperly aligned
implant.


Conformis


Clinical studies demonstrate that such compromises on fit can cause residual pain after
surgery. Conformis designs partial and total knee implants to fit the patient, not the other way around. They combine proven elements of standard knee replacement with iFit Image-
to-Implant® technology to create customized knee implants and surgical instrumentation designed to fit the knee’s natural shape and curves.

Conformis does something that we believe no other knee replacement company does. We
design and manufacture truly customized knee implants for both the femur and tibia. No
two implants are alike. Conformis’ femoral and tibial implants are individually sized and
shaped to fit to each patient’s unique anatomy, offering advantages often unachievable with
“off-the-shelf” knee implants.

iFit® Design
From image to implant, Conformis implants and instruments are based on each patient’s CT
scan. An automated design process maps the size and shape of the knee joint in 3D. Not
only does our proprietary software use that information to design the implants and
instrumentation to precisely match the resultant 3D model to the patient’s knee, it also
corrects the data to compensate for any underlying arthritic deformities such as bone spurs,
cysts, or flattening of the joint.


iFit® 3D Printing
iFit® 3D Printing is advanced manufacturing. Our disposable, patient-specific iJig®
instrumentation is manufactured using the latest in 3D printing technology. This allows us
to develop patient-specific instruments for every step of the procedure.

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NanoHealth USA®


NanoHealth USA is natural, wearable, cooling pain-relief technology. The science utilized in
NanoHealth pain relief wraps was used for years in the military, before being called upon
by EMTs, fire fighters, and other first-responders.


NanoHealth helps accelerate healing, particularly for patients recovering after surgery.
Doctor-recommended and clinically-tested, its benefits include being:

  • Cord free, battery free, and add-on part-free.
  • Reusable hundreds of time.
  • Ready to use in minutes.
  • Easily adjustable, enabling it to better stay in place.
  • Able to be used on-the-go.
  • Durable, breathable, and comfortable.
  • Drug-free.
  • Safe to wear directly against the skin, featuring an antimicrobial surface.
  • Temperature safe, with no risk of over-cooling.
  • Able to be used while sleeping.
  • An FDA Class I Medical Device.
  • Simple to clean.
  • Ready-to-charge, out of the box.
  • Proudly made in the U.S.A.

TriMed


TriMed offers numerous advanced and innovative orthopedic fixation systems, specializing in
small-fragment fracture fixation. As minimally-invasive alternatives to screw-fixation and
tension bands, their products are designed to be minimally invasive and to control fragment
rotation and translation.

Associated Videos:

For more information, check out these videos:

ConforMIS Image to Implant Process: http://www.conformis.com/customized-knee-
implants/image-to-implant-process/

Dr, Saves Skier’s Shattered Leg Amputation:

http://www.burlingtonfreepress.com/videos/news/2017/12/06/doctor-saves-skiers-
shattered-leg-amputation/108359976/