PTP: What are the latest trends in knee bracing?

Riley: In regard to rigid braces, custom and presized (off-the-shelf), there are essentially two primary types of braces that continue to be in high demand: functional braces for ligament injuries and instabilities, and osteoarthritis (OA) unloading-type braces to relieve the pain and mobility issues associated with unicompartment OA.

There continues to be reasonable growth in utilization of both types of braces, although functional bracing is more of a stable market, while OA bracing is a growth market. The trends for both types of braces is moving more to braces that are off-the-shelf due to insurance carriers being more reluctant to authorize payments for custom-made braces.

There has also been a consumer-driven movement toward braces that are lighter in weight, lower profile, and more cosmetically appealing. This is the buyers' influence toward products that are more patient friendly. For certain patients, this is fine. However, patients that are overweight or who have more serious clinical issues will achieve more functional benefits from a brace that has a more rigid, significant superstructure. In other words, lightweight, pretty braces are not appropriate for certain patients and body types.

OA bracing—which was a relatively new concept a decade ago—is experiencing more support from physicians and other medical providers. These braces can't cure the problem; they merely minimize the symptoms by preventing the leg from falling into an abnormal angulation and by shifting load away from the damaged side of the knee. Physicians are more readily prescribing these devices, particularly for patients who are too young for a total knee replacement. The ideal is to buy the patient time and provide them with more mobility and a higher quality of life until the patient is older or less active.

Ultimately, the patient will require surgical intervention—but physicians generally prefer to do surgery when a patient is not going to wear out the replacement joint. Revisions (replacement of the original artificial joint) are often not as successful as the original procedure; and the patient is older the second time around, which complicates the surgery and rehabilitation process.

One trend in OA braces is for the physician to prescribe the brace in conjunction with the use of injections (Synvisc and other products injected into the knee joint via a series of shots). The concept is that the OA brace will prolong the useful life of the lubricant by minimizing the load on the compromised compartment.

Another trend in terms of functional braces relates to the increased use of braces for prophylactic purposes to prevent a ligament injury. One only has to watch college football games on television to see the high percentage of interior linemen wearing bilateral knee braces to guard against lateral blows that can cause ACL or MCL injuries.

Rodgers: I see two recently strong trends in the knee bracing category: First, new technologies in materials and component parts are contributing to more effective, yet comfortable braces. For example, the latest in hinge technology is contributing to new ACL braces that offer stability without the cumbersome weight issue of old.

Second, injury-specific braces and supports, not available several years ago, are providing targeted support for certain injuries. For example, the Back of Knee compression wrap by Pro-Tec Athletics alleviates conditions of popliteal tendinitis, an injury which causes pain and inflammation to the back of knee region.

PTP: What are the top three issues that PTs should be most concerned with when fitting patients with—or advising patients on—a knee brace?

Riley: There is a common perception among practitioners and patients that all knee braces are virtually the same. In reality, the fabrication process and proprietary technology is substantially different between the various brace manufacturers.

If a patient and/or their insurance carrier is going to pay for a custom brace, they should make sure the brace being ordered is a genuine custom product. Generally, true custom braces are made with carbon-graphite shells, and ideally, the brace should be made from a positive model of the patient's leg—such as a cast mold or a digital leg scan. While there are a variety of measurement devices that can be used by providers when ordering a brace, nothing equals an exact replica of the patient's leg when it comes to fabricating a brace that will have an intimate fit and total shell-to-skin contact on the limb.

PTs need to make sure the product they choose, or the product the patient is using, is appropriate for their functional needs, their lifestyle, and their size. In other words, you can't treat every patient with a cookie-cutter brace. PTs need to take the time to learn about the various products available to patients, and to understand the differences in the design, fabrication, patented technology, and ordering options. Outcomes are enhanced when the product that is ordered matches the patient's clinical needs and lifestyle.

The Pro-Tec Hinged Knee features flexible straps, which do not dig into the thigh region.

The Premier Series brace by Townsend Design maintains total shell-to-skin contact throughout range of motion.

Also, in addition to function, PTs need to be concerned about patient compliance. The patient needs to be able to easily position and strap on the brace, and the brace needs to stay properly positioned throughout range of motion. Many braces do not have hinges that move anatomically with the roll-and-glide motion of the need joint. Often, this mechanical mismatch between the motion of the hinges and the motion of the knee will cause the brace to gap away from the leg or piston up and down on the leg as the patient bends and extends the limb. A brace that pistons has a much higher probability of having suspension issues due to the conical shape of the leg. Braces that don't suspend (that migrate) often end up in the closet, as the number one reason many patients cite for discontinuing the use of the brace is because it doesn't stay up on their leg.

A third issue that PTs need to understand is what to do if the patient is having an issue with their brace, or what to do if they feel the brace is not appropriate or is not being used by the patient. PTs can help ensure a higher level of patient compliance by assisting the patient with fitting issues, the appropriate procedure for putting on the brace, etc.

Rodgers: First, verifying that the brace matches the injury. Because of the injury-specific trend in bracing, many patients no longer need to rely on a general "warmth and compression" support for injuries, such as patellar tendinitis, iliotibial band syndrome, and lateral subluxation. For example, 10 years ago, patellar tendon straps were not commonly recommended for patellar tendinitis, and a common knee sleeve may have been suggested. Today, patellar tendon straps can be seen on countless individuals being treated for patellar tendinitis. The patellar tendon strap provides targeted compression on the tendon, stabilizing and reducing strain, making it far more effective than a simple sleeve. Additional examples are IT band syndrome and lateral subluxation, and the Injury Specific IT Band compression wrap and J Lateral Subluxation braces, respectively.

Second, sizing is an issue. Incorrect sizing can completely nullify the positive effects of bracing. A brace that is too big or loose may not provide adequate stability or support, while a brace too tight may cause extreme discomfort and reduce patient compliance.

Third, fully recovered patients will still benefit from bracing in certain circumstances. For example, despite full recovery from a ligament tear, a patient will most likely continue to be susceptible to knee weakness. If this individual plans to participate in any strenuous activity, like a sporting event, a knee brace may help prevent further injury. A stability or hinged-knee brace may be appropriate for this situation.

PTP: How has technology played a role in—or improved—your products' development?

Riley: We are constantly looking for new materials and designs to use to enhance patient outcomes—both in terms of clinical objectives and user-friendly qualities. At Townsend, we have substantially reduced the weight and profile of our braces to make the products more easy to wear under clothing and athletic equipment. We have also utilized a variety of testing devices to continuously find ways to increase the strength, durability, and longevity of the braces we fabricate.

Competition drives changes, and caused all manufacturers to continuously look at ways to improve the knee braces that are available to patients. Some changes are technically complex; others are simple in terms of how they enhance outcomes. An example of a simple modification is the use of silicone material on strap pads that aid in brace suspension. One company began offering this option, and now virtually all manufacturers offer these types of antimigration pads.

We benefit from listening to medical providers. We don't treat patients (see patients), so we don't have the advantage they do of visualizing the patient's anatomy or hearing about their mobility challenges. We get an order. So the more the practitioner can tell us about their specific patient, the better we can help the provider achieve a positive outcome. We have the ability to make modifications to the patient model (cast) and to include specific options and alternations to the brace based on our collective experience. More and more, other companies are mass producing braces outside of the United States, and they can't offer the level of customizing that we do at Townsend.

Rodgers: Software technology has expedited the initial design and prototype timetable dramatically. A sample hinge with a specified degree lockout feature could be taken through the design, mold, and prototype stages within a few days. This also speeds up the lead time for custom bracing.

For tips and information on bracing for patellofemoral dysfunction, read our May 2007 article, "Knee Know-How."

PTP: Tell us about your most popular product and what makes it effective.

Riley: Our Premier Series braces for functional instabilities and OA have become the leading products we sell. They are designed to address four specific criteria: control, comfort, convenience, and cosmesis. We can make these braces from a cast, a digital leg scan, or a leg tracing, which gives practitioners a variety of options for how to order the product. We offer more options than other manufacturers who make similar products, which increases the potential for a positive clinical outcome and high degree of patient compliance. We offer patented hinge motion and suspension technology that ensures the brace maintains total shell-to-skin contact throughout range of motion. This improves the functional control provided by our ligament braces and the continuously unloading provided by our OA braces. This proprietary technology on Premier Series braces also greatly reduces the potential for brace migration.

Our Premier Series braces generally weigh only 16 to 18 ounces, they are very low profile, and they have a nice cosmetic appeal (high gloss or powdercoat finish).

Rodgers: We have two products that have experienced exceptional sales growth over the last year. First, the I.T. Band Compression Wrap. This iliotibial band support is effective because it provides targeted compression directly on the I.T. Band (approximately 3 to 4 inches above the top of the patella), which stabilizes the I.T. Band, thereby reducing friction and irritation to the femoral condyle on the outside of the knee.

Second, in addition, our Hinged Knee Brace has seen strong year-over-year sales volume. It has provided many patients the necessary stability with increased comfort. While most Hinged Knee Braces use static straps above and below the knee, the Pro-Tec Hinged Knee implements flexible straps, which will not bind or dig into the thigh region throughout the patient's complete range of motion.

PTP: How are patients' needs evolving in your niche?

Riley: Surgical improvements, and better rehab protocols, have helped improve outcomes for patients who experience ACL injuries. Depending on the patient's activity level, some can resume activities without the use of a knee brace. However, braces provide another layer of protection and provide a certain degree of proprioceptive protection as well. Patients like the peace of mind that comes from wearing a brace and have a subconscious reminder that they injured their knee and don't want to go through that ever again in their lifetime.

The aging of America—the Baby Boomer generation—has created a huge population of OA patients who want to remain active into their senior years. A total knee procedure limits the activities they can participate in, while a brace allows them to do virtually any type of activity. We feel there are many more patients who could benefit from a knee brace that are not even aware this type of device exists. PTs who may be treating a patient for another medical issue are in a position to identify candidates for an OA knee brace that can enhance the patient's physical mobility and overall heart health by allowing the patient to be more active due to the reduction of knee inflammation and knee pain.

Patients have tremendous access to information about bracing and knee problems on the Internet. The Web sites they can go to, and helpful tips available on various Web sites, allow them to be more informed consumers. They can shop for a knee brace—in terms of gathering information and forming opinions to be able to ask informed questions—and have a better understanding of how a brace can enhance their quality of life.

Rodgers: One of the most prevalent needs in today's market is a brace that will not inhibit the athlete's performance, yet will still provide the necessary support and stability. New innovations in materials and component parts, as well as brace designs that are less cumbersome and more injury specific, are providing the athlete with a means to stay actively supported without the distraction of a cumbersome, heavy brace. This is also true for the nonathlete, as patient compliance is affected by the obtrusiveness as well as the effectiveness of the brace or support.

Arati Murti is the editor of Physical Therapy Products. For more information, contact .