Brace name SoftTec OA (off the shelf) (from: http://www.bauerfeind. com/file/index/view/file.id/339) Description Indications Bauerfeind 1. SoftTec knit provides high degree of tension stability and muscle play. 2. Two viscoelastic pads above and below kneecap to counteract swelling and hematoma during motion. 3. Two zippers for easy fitting. 4. Four nonelastic straps on the upper and lower legs permit fine adjustment and secure brace against any rotational forces with movement. 5. Anatomically contoured carbon fiber sidebars that can be heated and reshaped. 6. Contour shells can be heated and adapted to individual’s leg shape and are connected by flat duocentric hinge that transfers load of knee. 7. Valgus pressure is adjusted by filling and emptying air bladder. 8. Silicone pads positioned between air bladder and surface of leg. Medial osteoarthritis Features 1. Easily adjusted. Warranty Six-month warranty $800.00 2. Easy to don and doff. 3. Breathable 4. Available in plus sizes. 5. 3-point pressure relief principle. (Continued on next page) 7 Osteoarthritic Knee Braces on the Market Manufacturer Approximate price list; prices vary with vendor Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Table 3. Osteoarthritis knee braces available within the United States as of January 2013 Brooks 8 Brace name Manufacturer DUO (Dynamic Unloading Bledsoe Osteoarthritis) Brace (off the shelf and custom) (from: http:// bledsoe brace.com/products/ pdf/datasheet/soe_strong_oa_ brochure.pdf) Description Legacy Thruster OA (off the shelf or custom) (from: http://bledsoe brace.com/products/pdf/datasheet/ soe_strong_oa_brochure.pdf) Bledsoe Indications 1. Was Thruster 2 1. For moderate to severe OA. 2. Low-profile frame 2. For all-day use 3. Double upright 3. OK for individuals with redundant tissue. 4. Dynamic loading hinge 4. OK running (0Y5 mph) 5. OK golf, bowling 5. Incremental arm adjustments 6. Unique strapping prevents migration 1. Low-profile single-upright 1. For mild to moderate OA 2. Hinge is on affected side 2. For moderate to of knee, which creates relief severe OA patients. by pulling the straps to open the joint space versus pushing against the opposite side of the knee. 3. Dial allows incremental 2. For all-day use. fore adjustments. 4. Distal calf section flexes 3. OK for moderate with the muscles of the leg. activities such as walking, golf, tennis, bicycling. 5. Up to 22- of correction 4. Not OK for high-intensity sports such as football, basketball, or skiing. 5. OK minimal running (0Y10 mph) Features Standard frame length 15 in Frame lengths come in short (14 in) and standard (16 in). Warranty Off Approximate price list; prices vary with vendor the shelf and custom: 1. Off the shelf: $599.99 1. 90-day warranty on soft goods. 2. 1 year on mechanical functionality/ components 3. 3 years on hinge functionality/components 2. Custom: $1500 Off the shelf and custom: 1. 90-day warranty on soft goods. 2. 1 year on mechanical functionality/components 3. 3 years on hinge functionality/components 1. Off the shelf: $599.99 2. Custom: $2000 Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Table 3. (Continued) Breg 1. For medial compartment OA that reduces elongation of ligaments. 2. Double-upright frame. 2. Not indicated for lateral compartment OA. 3. Precise contoured fit ‘‘pre-tensions’’ the medial side of the brace, which allows brace to engage sooner, resisting knee displacement. 3. Designed for athletic and normal daily activities. Note: There is a Fusion Lateral OA knee brace that is similar in design to the Fusion OA but specifically designed for lateral unicompartmental OA with an off gauge that displays the amount of load applied in half-millimeter increments. 1. There is a Women’s Fusion OA and Men’s Fusion OA version as well as a stronger Fusion XT OA that is designed for higher-impact strength. 2. Women’s Fusion OA is available only in wrinkle coat finish, and white is available only in custom version that weighs 20 oz. 1. One year hinge Off the shelf: $529.99 2. Straps/frame pads are 6 months. Fusion Women’s OA Fusion XT OA 4. Allows medial side to accommodate changing axis of knee through flexion and extension that keeps the brace solidly in place. (Continued on next page) 9 Osteoarthritic Knee Braces on the Market 1. Brace made from DuPont’s Zytel ST, a strong flexible polymer that conforms to the shape of the leg. Journal of Prosthetics and Orthotics Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Volume 26 & Number 1 & 2014 Fusion OA (off the shelf) (from: http://www.breg.com) Brooks 10 Brace name Defiance OA (off the shelf and custom) (from: http:// www.djoglobal.com/our -brands/donjoy/) Manufacturer Donjoy Description 5. Zytel is combined with lightweight, high-strength 2024 tempered aluminum. 6. Has a thumbwheel dial hinge that makes it easy to adjust the level of offloading. 1. Double upright with a four-point leverage system. Indications 1. For medial or lateral compartment OA. 2. There is a 1- to 72. Moderate to severe correction built into unicompartmental OA a strong, lightweight, carbon composite frame. 3. Has a telescoping condyle pad with up to 3- of additional correction that shifts the compressive knee joint forces to the nonaffected compartment. 4. Has a universal OA key for patient-controlled load adjustments to meet daily needs. 5. Floam condyle pad with 100% memory for increased comfort and compliance. 6. Has a swooping thigh cuff for inner thigh clearance and bilateral brace use. 7. Sili-Grip strap pads 8. Neoprene suspension straps. 9. Antimigration band anchors on the upper calf. Features Warranty Approximate price list; prices vary with vendor 1. Available in 40 custom frame colors and graphics. 2. Has swivel strap tabs to accommodate leg movement. 3. Available in standard or short length frame. 4. Flexion and extension control. Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Table 3. (Continued) OA Nano (off the shelf) (from: http://www.kneeshop.com/ productcart/pc/PROFESSIONALBRACES-C42.htm9) Donjoy Donjoy 1. Four-point leverage system. For moderate to severe unicompartmental OA 1.Weighs 23 oz. 1. One year on frame and hinges. 2. Lock and off-Load Technology shifts compressive knee joint forces from degenerative side to healthy compartment. 3. Universal OA key allows for patient-controlled load adjustments. 4. Floating hinges allow a contoured fit with a double-upright design. 5. Lightweight, aircraft-grade aluminum frame. 6. Has a swooping thigh and calf cuffs for inner leg clearance. 7. Swivel D0Rings accommodate for leg movement. 8. Has antimigration band that anchors upper calf. 9. Floating hinges allow a contoured fit with double-upright design. 10. Hinge is on opposite side of OA. 1. Similar to Donjoy’s For mild to moderate OA Adjuster but lighter medial and lateral in weight. unicompartmental OA. 2. Has 20- of varus or valgus range. 2. 6 months on soft goods 3. Arthritis friendly 4. Is 14.5 in length 1. Light: 14.2 oz 1. One-year warranty on frame and hinges. 2. Provides offloading on lateral or medial side. 2. Six-month warranty on soft goods. $674.99 (Continued on next page) 11 Osteoarthritic Knee Braces on the Market 2. Double-upright rigid knee brace. 3. Has Lock and off-Load Technology that shifts compressive knee joint forces from degenerative area to healthy compartment. 4. For people who stay active and move freely. 5. Malleable nano magnesium frame allows cuff adjustments and provides strength to offload. 6. Contoured designed and brace suspension keeps knee brace in place and prevents slipping. Off the shelf: $649.99 Journal of Prosthetics and Orthotics Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Volume 26 & Number 1 & 2014 OA Adjuster (off the shelf) (from: http://www.djoglobal. com /our-brands/donjoy/) OAsys (off the shelf) (from: http://www.ossur.com) Manufacturer issur Description 1. Double-upright brace. Indications 1. Medial or lateral compartment OA. 2. Equipped with Accutrac 2. Can be used with low and ROM hinges with easy-to-use medium contact/impact flexion and extension stops. activities. Unloader ADJ (custom) (from: http://www.ossur.com) issur 3. Acculign slide bar for medial and lateral unloading. 4. Heat moldable frame for customized fitting by O&P clinicians. 5. Pivoting, quick-release buckles and four-strap design for easy donning and doffing. 6. Gel Fit condylar pads for joint line comfort and to cushion bony prominences for improved patient satisfaction and compliance. 7. Reduce medal surface area for streamlined fit and comfort on fleshy legs. 8. Made of noncorrosive materials that are ideal for water sports. 9. Lightweight frame 1. Designed on the same principles 1. For OA knee patients as the ‘‘Unloader Select.’’ with mild to severe unicompartmental OA 2. Shell is more flexible to 2. For patients with conform well to wide thighs excessive soft tissue and calves, whether patient is weightbearing or not. 3. Has wider elastic straps to contain excess tissue. 3. Ideal for geriatric populations. Features Available in silver, champagne, or carbon fiber finish. Warranty 1. Frame and hinge components warranted free of defects in materials and workmanship for 2 years. 2. Straps, liners, return cords, hinge coatings, and other soft components warranted free from defects in materials and workmanship for 6 months. $699.00 $685.00 1. Color-coded tabs/D rings 1. Frame and hinge components warranted and numbered straps with free of defects in materials EZ Grip loops to make and workmanship for lifetime donning and doffing easy of the original patient. for patients with limited cognition and/or manual dexterity. 2. There are 12 colors 2. Straps, liners/covers, sleeves, to choose from. return cords, other soft components warranted free from defects in materials and workmanship for 6 months. Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Brace name Approximate price list; prices vary with vendor Brooks 12 Table 3. (Continued) issur 2. CoolFlex material provides 2. Not recommended 2. Removable sleeve is excellent wicking and drying. for high-contact sports. machine washable. Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 1. Frame and hinge components warranted free of defects in materials and workmanship for 2 years. 2. Straps, liners, return cords, hinge coatings, and other soft components warranted free from defects in materials and workmanship for 6 months. $599.00 3. Has a Dynamic Force Strap 3. Not recommended for offloading. for patients with excess soft tissue. 4. Has a single upright on 4. Good for mild cognitive/ affected side, combines with or manual dexterity Dynamic Force Strap to create deficiencies. 3-Point Leverage System. 5. Clinician-controlled varus/ 5. Good for low to valgus adjustment. moderate ADLs. 6. Semirigid shells. 7. issur Poli-Axial Hinge System. (Continued on next page) 13 Osteoarthritic Knee Braces on the Market Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Unloader Express (was Generation II Express) (off the shelf) (from: http://www.ossur.com) 4. Dynamic Force Strap for 4. For individuals with counteracting force to disproportionate thigh unload affected compartment. to girth, abnormal leg contour, thin skin, minimal muscle mass, and/or mild cognitive deficiency. 5. Single upright on affected 3. For low to demanding ADLs. side with Dynamic Force Strap to create 3-Point Leverage System. 6. Adjustable dynamic Joint for clinician to control varus/valgus. 7. Wide elastic straps for excessive soft tissue. 8. Washable doeskin liners wick moisture and keep leg cool. 1. CoolFlex sleeve with a 1. Early-onset OA 1. Cost-effective. semirigid frame. patients. Brooks 14 Table 3. (Continued) Manufacturer Unloader One (off the shelf and custom) issur (from: http://www.ossur.com) Unloader Select (custom) (from: http://www.ossur.com) issur Description 1. Dual dynamic Force Straps increase unloading capabilities and prevent rotation of the brace on the leg. 2. Tool-free, racheting Dynamic Force Control System enables self-adjustment for easier pain management. 3. Breathable liners featuring issur Sensil Silicone on an Aerospacer base material virtually eliminates migration. 4. Flexible, low-profile, hinged upright contours to individual anatomy and allows use underneath clothing. 5. Quick Connect Strapping for tool-free removal and replacement. 6. Lightweight frame is perforated for flexibility and ventilation. 1. Single upright on affected side combined with Dynamic Force Strap creates three-point leverage system. 2. Has an Adjustable dynamic Joint that allows clinician to control varus or valgus force for pain management. 3. Carbon Triax shells provide rigidity. 4. Flexion and extension stops control ROM. Indications 1. Mild to moderate unicompartmental OA Features Short versions available for those 5 ft 2 in or shorter. 2. Thigh circumferences of 13.5Y29 in Warranty 1. Off the shelf: 1. Frame and hinge $533.47 components warranted free of defects in materials and workmanship for 2 years. 2. Straps, liners, return cords, 2. Custom: $721.00 hinge coatings, and other soft components warranted free from defects in materials and workmanship for 6 months. 3. Calf circumferences 9.8Y24 in 4. For noncontact activities. 1. Mild to severe 1. Washable doeskin liners unicompartmental OA. wick moisture and keep leg cool. 1. Frame and hinge components warranted free of defects in materials and workmanship for 2 years. 2. For disproportional 2. Comes in 12 colors. thigh-to-calf girth, abnormal limb contour, thin skin, minimal muscle mass, and/or mild cognitive deficiency. 3. For low to demanding ADLs 2. Straps, liners, return cords, hinge coatings, and other soft components warranted free from defects in materials and workmanship for 6 months. $697.00 Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Brace name Approximate price list; prices vary with vendor issur 1. Mild to severe 1. Sleeveless, single-upright unicompartment OA. and cost wise one step down from the Unloader One. 2. Single upright on affected 2. Not recommended for side with Dynamic Force high-contact sports. Strap to create 3-Point Leverage System. 3. Adjustable Dynamic Joint 3. Not recommended allows for varus/valgus for patients with excess alignment. soft tissue. 4. For low to moderate 4. Adjustable Tibial Strap captures tibia and allows ADLs. adjustments in hinge depth for customized fit. 5. T-6 black anodized aluminum hinge. 6. Lightweight (18 oz). 7. Thigh circumferences of 13.5Y26.5 in at 6 in above midpatella. 8. Has removable line and trimmable straps/pads for customization. 9. Extension stops for partial ROM control available at 5-, 10-, and 1510. Flexible Triax shells are low profile, which are moderately adjustable for patient anatomy. 11. Antimigration strap design. Available in medial or lateral models. 1. Frame and hinge components warranted free of defects in materials and workmanship for 2 years. 2. Straps, liners, return cords, hinge coatings, and other soft components warranted free from defects for 6 months. $699.00 Journal of Prosthetics and Orthotics (Continued on next page) 15 Osteoarthritic Knee Braces on the Market Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Volume 26 & Number 1 & 2014 Unloader Spirit (was Generation II Spirit) (off the shelf) (from: http://www.ossur.com) Manufacturer Genu Arthro 28K20/21 (off the shelf) (from: http:// www.ottobock. com/cps/rde/xchg/ ob_com_en/hs.xsl/619.html) Otto Bock Description 1. Unilateral joint Indications Features Warranty Medial or lateral unicompartmental OA 2. Frame pad made of breathable Soft Tex 3. Lightweight tube frame 4. Based on 3-point principal to unload affected compartment. 5. Easy-to-use belt pad closures. 6. No rigid thigh components. 7. Has a long lever arm and low-profile foot stirrup that prevents upward and downward migration. BioniCare Knee System: (http://www.bioncare.com) a. OActive Knee Brace (off the self and custom) VQ Orthocare 1. BioniCare System offered in conjunction with three types of braces: Knee pain associated with OA BioniCare System contraindicated for individuals: 1. Bionicare system has a 1-year warranty. 1. Bionicare System: $1795.00, which includes a 3-month supply of electrodes and $89.50 for additional 3-month electrode supplies afterward. Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Brace name Approximate price list; prices vary with vendor Brooks 16 Table 3. (Continued) c. Bionicare Night-Wrap (off the shelf) a. OActive Knee Brace. 1) Single lateral upright frame 1. With a demand-type cardiac pacemaker. 2. OActive Knee Brace Custom and Eagle OA Knee Brace Custom both have a 10-year warranty on frame and cuff, 3-year warranty on hinge, 6-month warranty on soft goods, and a 90-day fit guarantee. 2. OActive Knee Brace Custom: $2785.00 2. During pregnancy or birth 3. OActive Knee Brace off the shelf has a 1-year warranty on the hinge, 6-month warranty on soft goods, and 30 days to return from time of purchase. 3. OActive Knee Brace off the shelf: $1540.00 17 Osteoarthritic Knee Braces on the Market (Continued on next page) Journal of Prosthetics and Orthotics Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Volume 26 & Number 1 & 2014 b. Eagle OA Knee Brace (custom) d. Bionicare System (off the shelf) contact electrodes Bionicare System with Bionicare Night Brace Manufacturer Description 2) Angle adjustment to unload medial or lateral compartments of the knee 3) Lightweight design Indications Features 3. Allergic to adhesive on electrodes Warranty 4. Eagle OA Knee Brace custom: $2215.00 5. Bionicare Night Wrap is included in Bionicare System cost of $1795.00. Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Brace name Approximate price list; prices vary with vendor Brooks 18 Table 3. (Continued) Journal of Prosthetics and Orthotics Volume 26 & Number 1 & 2014 19 (Continued on next page) Osteoarthritic Knee Braces on the Market Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. 4) Low profile that can be worn under clothing. 5) Lateral application avoids contralateral limb and tibial crest pressure issues. 6) Quick-release buckles for easy donning and doffing. 7) Sili-grip liners and strap pads for suspension. 8) Available in off the shelf or custom b. Eagle OA Knee Brace: 1) Double-upright frame 2) Active Thigh Cuff maximizes suspension 3) Lightweight 4) Sili-grip strap pad for suspension 5) Available custom only. c. Bionicare Night-Wrap: Neoprene sleeve with Velcro closing system. 2. Bionicare System: Has three major components: 1) Signal applicator: a) Black, lightweight, soft wrap that closes with Velcro and holds the contact elements/ electrodes. b) Kept in place with a suspended strap and waste band 2) Signal generator: a) Four-ounce battery-powered unit that generates a subthreshold proprietary electrical signal (up to 12 V of DC current) b) Uses a rechargeable 9-V battery that keeps a record of treatment. c) Has two channels that allow both knees to be treated simultaneously. d) Worn under clothing and during sleep. Brooks 20 Brace name Manufacturer Description Indications Features Warranty Approximate price list; prices vary with vendor 3) Contact elements: a) Snap-in electrodes that are replaceable. b) Two electrodes are used: 1 Treating electrode over the knee joint. 2 Return electrode placed on thigh. ADLs, activities of daily living; OA, osteoarthritis; O&P, orthotic and prosthetic; ROM, range of motion; DC, direct current; V, volts. Journal of Prosthetics and Orthotics THRUSTER 2/DYNAMIC UNLOADING OSTEOARTHRITIS KNEE BRACE The ‘‘Thruster 2’’ by Bledsoe is no longer available and has been replaced by the DUO brace. The designs of the DUO and the Thruster 2 are similar (refer to Table 3 for DUO picture). Like the Thruster 2, the DUO is the only double-upright ‘‘dynamic’’ OA brace on the market that creates a load across the joint when the knee is straight and reduces the load when the knee is flexed. The brace is popular because it can be used all day and is indicated for low activity levels such as golf and bowling as well as for patients with redundant tissue. Dennis et al.69 performed two investigations using the Thruster 2 brace. The first investigation fitted 45 individuals with a Thruster 2 brace with symptomatic medial unicompartment OA. Forty of the subjects were fitted with a Thruster 2 brace according to the guidelines provided by the manufacturer, and the other five subjects were simply given a Thruster 2 brace and not instructed in how to offload the degenerated compartment. Successive fluoroscopic images were performed on each individual in stance phase on a treadmill with and without their brace. The results of the first study revealed the following: 1) 85% of the subjects (34/40) with the properly applied Thruster 2 brace experienced reduced knee pain, and fluoroscopic images demonstrated medial condylar compartment separation, and 2) 15% of those (6/40) who did not have a properly fitted brace reported a lack of pain relief and did not demonstrate any increase in condylar separation magnitude or angle. The lack of pain relief within the six participants was explained as caused by a loosely applied brace that did not cause condylar separation, and in one case, the participant was obese and the brace did not fit properly.69 In the second investigation, Dennis et al.69 once again used five subjects with symptomatic medial unicompartment OA. Each subject was fluoroscoped while performing normal gait on a treadmill wearing five different offloading braces to analyze the effectiveness of each brace. The five offloading braces were the Bledsoe Thruster 2, Donjoy OA Adjuster, issur OAsys, issur Generation II, and an anterior cruciate ligament brace. The results of the second investigation identified the following information: 1) the ACL brace revealed no medial compartment separation during the stance phase of gait; 2) all five offloading braces experienced the greatest medial condylar separation at heelstrike compared with the midstance and toe-off phases of gait; 3) the Bledsoe Thruster 2 and the Donjoy OA Adjuster provided the greatest amount of condylar separation at heelstrike compared with the other three braces; 4) the Bledsoe Thruster 2 was the only brace that produced the greatest condylar separation at midstance and toe-off; 5) the Donjoy OAdjuster had the second best condylar separation with toe-off; and 6) overall, the Bledsoe Thruster 2 and Donjoy OAdjuster braces provided the greatest amount of condylar separation during all five analyzed gait phases.69 Another article written by Hewett et al.51 collected information on 18 patients who were fitted with the Bledsoe’s Thruster 2 for a period of 1 year. The subjects had been Volume 26 & Number 1 & 2014 Copyright @ 2013 by the American Academy of Orthotists and Prosthetists. Unauthorized reproduction of this article is prohibited. Table 3. (Continued)