US20020077574A1 - Joint brace for medial/lateral loading - Google Patents

Abstract

Braces for loading and/or unloading knees, elbows and other joints. Such braces feature a stiffener which may be substantially permanently configured in shape to cooperate with the brace in applying tension to locations on the limb proximal and distal to the joint being loaded and/or unloaded, which counteract forces applied by the stiffener to the joint. A bending tool which may be accompanied by use of a goniometer may be employed for proper configuration of the stiffener using the wearer's limb geometry as a reference. Such braces are particularly effective for treating conditions such as compartmental osteoarthritis.

Description

RELATED APPLICATIONS
• The present application is a divisional of pending U.S. patent application Ser. No. 09/589,894, filed Jun. 7, 2000, which is a divisional of U.S. patent application Ser. No. 09/326,384, filed Jun. 4, 1999, now abandoned. The entire contents of these prior applications is hereby incorporated by reference.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• The present invention relates to braces for applying forces to knees and other joints in a medial/lateral plane or as otherwise desired. Such braces employ stiffeners which may be preferably removed and configured to a desired shape for imparting a predetermined force on the joint when employed in the joint brace.[0003]
• 2. Description of the Related Art[0004]
• Conventional approaches to compartmental osteoarthritis and other joint maladies have included placing a brace on the limb surrounding the joint. Such braces aim to impart force or leverage on the joint in order to relieve compressive forces within a portion of the joint, or to reduce the load on that portion. For instance, in knee compartmental osteoarthritis situations, braces have been employed which feature rigid bars situated on the leg opposite or adjacent to the affected compartment of the knee. The bars include medial/lateral hinges which allow portions of the bars to be pivoted or swiveled in the frontal (varus/valgus) plane with respect to one another and locked into a desired configuration. The brace so configured when installed on the knee then imparts leverage at least partially to unload the affected compartment, and the adjustable hinges allow the magnitude of the force to be controlled or varied. Such adjustable hinges may employ set screws or other adjustment structure. Often, however, the adjustment structure requires use of a special tool and virtually always introduces bulkiness accompanied, paradoxically, by structural compromise and complexity.[0005]
SUMMARY OF THE INVENTION
• The present invention provides braces for loading and unloading joints which alleviate the need for medial/lateral structure configuration adjustment devices such as hinges. Braces according to the present invention include a stiffener. The stiffener is preferably removably attached to the brace so that it can be adjusted in configuration while apart from the brace. The configuration of the stiffener may be permanently or substantially permanently adjusted or deformed by bending. In one version of the invention, the bending may occur in a bending tool which may include a goniometer for measuring the degree of deformation of, and the consequent loading to be applied by, the stiffener.[0006]
• The stiffener so placed in the bending tool and bent to a desired configuration is deformed in a manner that is permanent or at least substantially permanent in the range of temperatures and forces encountered by the average brace wearer. The stiffener so configured is attached to or inserted in the brace, which may be formed of elastic, non-elastic or partially elastic material. The brace when installed properly on a limb loads or unloads portions of the joint with a predetermined force, a proxy for whose magnitude may, but need not be, determined by measuring a patient's limb alignment with a goniometer and configuring the stiffener with a bias relative to the patient's limb alignment. The amount of bias then corresponds to the magnitude of that force.[0007]
• The stiffeners may be formed of metal, in which case bending for permanent or substantially permanent deformation may occur at room temperature. Stiffeners may also be formed of desired plastics or composite materials in which case bending for permanent or substantially permanent deformation can occur while heated; when the stiffener returns from its temperature excursion to the normal range of temperatures encountered by brace wearers, the deformation imparted by the bending is permanent and/or semi-permanent. That is, application of loads to the stiffener while the brace is in use does not cause the shape of the stiffener to “creep” or relax back to its previous, preconfiguration shape, or to suffer substantial plastic deformation. The stiffener instead “springs back” to its deformed configuration when the loads are removed.[0008]
• It is accordingly an object of the present invention to provide knee braces for medial/lateral loading and unloading of body joints which employ stiffeners whose configuration may be readily adjusted to control the degree of loading and/or unloading, but which are inexpensive and efficient to manufacture.[0009]
• It is an additional object of the present invention to provide braces for loading and unloading body joints whose stiffeners may be configured in shape without the need for special hinges or configuration structure such as set screws.[0010]
• It is an additional object of the present invention to provide braces for loading and unloading body joints which include stiffeners whose configuration may be adjusted to a desired shape using a measuring device which may be adjusted to conform to the geometry of the leg and then used to configure the stiffener to apply proper loading.[0011]
• It is an additional object of the present invention to provide braces for loading and unloading body joints whose stiffeners may be configured in shape using a bending tool and accompanying goniometer to control conformance to limb geometry, and/or, if desired, the magnitude, recordability and repeatability of the configuration change and consequent loading/unloading on the body joint.[0012]
• It is an additional object of the present invention to provide braces for loading and unloading body joints whose stiffeners may be manually configured simply by being bent to a desired and predetermined shape to control and impart loading and/or unloading to the body joint, but which do not relax back to their non-configured shape as a result of such loading and/or unloading.[0013]
• It is an additional object of the present invention to provide braces for loading and unloading body joints and which may be easily and quickly adjusted by a clinician in a manner that requires only a single visit by the patient.[0014]
• Other objects, features and advantages of the present invention will become apparent with respect to the remainder of this document.[0015]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a front elevational view of a brace according to a first embodiment of the present invention.[0016]
• FIG. 1A is a front elevational view of a brace according to a second embodiment of the present invention.[0017]
• FIG. 1B is a schematic front elevational view of a brace according to a third embodiment of the present invention.[0018]
• FIG. 2 is a rear view of the brace of FIG. 1.[0019]
• FIG. 3 is a left side elevational view of a second embodiment of a brace according to a third embodiment of the present invention, showing a stiffener in outline.[0020]
• FIG. 4 is a perspective view of a bending tool according to the present invention for controllable configuration of the stiffeners of the braces of FIGS.[0021]1-3.
• FIG. 5 is a rear perspective view of the bending tool of FIG. 4 in combination with a goniometer according to a preferred embodiment of the present invention.[0022]
• FIG. 6 is a perspective view of a brace stiffener according to a preferred embodiment of the present invention inserted into a bending tool with accompanying goniometer for controllable configuration and consequent body joint loading and unloading when the stiffener is installed in the brace and the brace properly applied; here, the stiffener is configured neutrally before being configured to load the knee as desired when installed in the brace of FIG. 1.[0023]
• FIG. 7 is a top plan view of a brace stiffener according to a preferred embodiment of the present invention inserted into a bending tool with accompanying goniometer for controllable configuration and consequent body joint loading and unloading when the stiffener is installed in the brace and the brace properly applied; here, the stiffener is configured to apply relatively large force to the knee when installed in the brace of FIG. 1.[0024]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• FIGS. 1 and 2 show a first embodiment of a[0025]brace10 according to the present invention. Brace10 is shown applied on the left leg of a wearer. FIG. 1 is a front-on view of the left leg of the wearer, while FIG. 2 is a rear view of the left leg of the wearer with thebrace10 applied.
• Brace[0026]10 shown in FIGS. 1 and 2 is formed of asleeve12 in combination with a number of other components.Sleeve12 may be formed of any desirable fabric such as fully-, non-, or partially-stretchable fabric which may or may not be breathable.Sleeve12 may be fabricated using conventional stitching to conform to knees, elbows or other body joints as desired. Sleeve12 in the embodiment shown in FIGS. 1 and 2 features a knee cap opening14 in order to alleviate pressure directly on the patella and, if desired, for stabilization of the patella relative to other parts of the knee. In the embodiment shown in FIGS. 1 and 2, opening14 initiates a discontinuity insleeve12 which allows adjustment dimensionally about the thigh. The discontinuity shown in FIGS. 1 and 2 is aflap16.Flap16 cooperates with acorresponding section18 ofsleeve12 to allowflap16 to be fastened removably tosection18 so that the upper orproximal portion20 ofsleeve12 may be dimensioned to the body part (here, thigh) for a comfortable, secure fit. (Distal portion21 ofsleeve12 could also contain a discontinuity if desired.)Flap16 may be removably attached tosection18 using hook and loop fastener or any other desired fastening structure.Sleeve12 need not contain any discontinuity such asflap16/section18, orknee cap opening14.Flap16 may be oriented at any angle or direction as desired; its leading edge may be inclined, as shown in FIG. 1, for example, or the opposite direction.
• [0027]Sleeve12 contains on one side (which may correspond to the lateral or medial side of the leg or other limb when the brace is worn) astiffener22 which may be removably enclosed in astiffener sheath24.Sheath24 may be a fabric section sewn tosleeve12, a pocket, or any other structure which attachesstiffener22 tosleeve12, whether removably or in a manner which fixes the position ofstiffener22 relative tosleeve12. In the preferred embodiment,sheath24 is a pocket structure formed by stitching material tosleeve12; the pocket is generally configured in shape to conform to the shape of thestiffener22. A slit23 at one end of thesheath24 allows thestiffener22 to be inserted and removed. Stiffener22 and portions of thesheath24 may feature hook and loop patches in order to reduce the possibility that stiffener22 would rotate relative tosheath24 andsleeve12.
• The side of[0028]sleeve12 opposite the side featuring thestiffener sheath24 may include ananchor26 such as a tube or additional thickness of material sewn or otherwise attached to thesleeve12.Anchor26 may help reduce or limit migration and bunching ofsleeve12. Such lines ofstitching28 and additional material are not required, but they may be employed as desired for additional stabilization, cushioning, fit and feel.Stiffener sheath24 andanchor26 may also serve as an anchor for distribution of forces from lines of stitching28 or other portions ofsleeve12 orbrace10.
• [0029]Brace10 shown in FIG. 1 also includes at least two tensioningstructures30 for applying tension to portions ofstiffener22 relative to the body part distally and proximally of the joint circumscribed by thebrace10. In the embodiment shown in FIGS. 1, 2 and3,tensioning structures30 may bestraps32 which may be, but need not be, fastened tosleeve12 and which may be tightened and fastened to themselves or portions ofbrace10 in order to tension stiffener22 portions relative to the limb being treated. In the embodiments shown in FIGS. 1, 2 and3, tensioning structures30 (straps32) are attached to thesleeve12 by stitching atloops34, which may be plastic D rings or other devices.Loops34 obviously need not be included.Straps32 preferably circumscribe the leg of the wearer; one end with hook/loop fastener material extends through aloop34 and fastens back onto itself for a 200°/a mechanical advantage using hook/loop material on another portion of thestrap32. Tensioningstructures30 may be any structure, whether or not attached tosleeve12 or constituting portions of thesleeve12, which tension portions ofstiffener22 against the body part to which thebrace10 is applied. Tensioningstructures30 may, for instance, as shown in FIG. 1A, be portions ofsleeve12 or structures withinsleeve12. Elastic or nonelastic members, members integral to or that are simply a part ofsleeves12 and any other structure appropriate to tension stiffener22 portions against the leg or body part both distally and proximately of the joint can serve the function of tensioningstructures30 according to present invention, regardless of what particular structural niceties may be involved or which particular way they may apply such tension. The effect or result is to causestiffener22 to pull both distal and proximal portions of the limb towardstiffener22 while pushing the joint circumscribed by the brace away fromstiffener22 thereby to impart relative force or leverage to the joint and thus reduce the load on the side of the joint opposite to the side in which stiffener22 is located. (Such reduction in the loading on portions of a joint, whether partially or completely may sometimes be referred to as “unloading.” Simultaneously with such unloading, complementary loading of other portions of the joint occurs. Accordingly, the application of force on part of or all of the joint by stiffener or brace or portions of them may be referred to as “unloading,” “loading,” “reducing the load” on the joint or portions of it.)
• In the embodiment shown in FIG. 1, the[0030]stiffener22 on the lateral side of the left knee reduces the load on the medial compartment of the knee for treatment of medial side compartmental osteoarthritis of the knee.Brace10 may be manufactured for the left and right legs, respectively, and further manufactured for unloading of lateral or medial sides of the joint for each of those legs. Thus, for instance, two versions of left leg braces may be manufactured, one accommodating astiffener22 on its lateral side for treatment of the medial side of the knee, and one for accommodating astiffener22 on its medial side for unloading of the lateral side of the knee.Brace10 may also be manufactured to feature astiffener sheath24 on each of its sides for treatment for medial or lateral side of the joint, and/or for left or right limb, in order to minimize inventory and manufacturing diversity requirements.
• FIGS. 1 and 1A also show (in relief) an inflatable cushion or[0031]condyle64 interposed between thestiffener22 and the joint being treated. Thecondyle64, which may be a conventional inflatable condyle, may be inflated using aconventional inflation device68 such as shown in FIG. 1A, throughslot66 insleeve22. Inflation/deflation modes ofhand pump device68 may be mediated through valve control andvalve70. Other sorts of condyles, including non inflatable ones, and other sorts of inflation devices may also be used.
• FIG. 2 shows a rear view of the brace shown in FIG. 1, and FIG. 3 shows a side view of a brace whose[0032]straps32 are attached on the side of thebrace10 on whichstiffener22 andstiffener sheath24 are located.
• FIG. 1B shows in a schematic manner another embodiment of a[0033]brace10 according to the present invention where thestiffener22 is to be located on the same side of the knee as the compartment to be unloaded. Here,proximal portion36 anddistal portion38 of thestiffener22 are curved inward toward the limb, rather than outward from the limb as in FIG. 1. The effect or result is to causestiffener22 to pull the joint circumscribed by thetensioning structure80 towards thestiffener22 while pushing both distal and proximal portions of the limb away from the stiffener.
• FIG. 3 shows a[0034]stiffener22 in relief enclosed in astiffener sheath24.Stiffener22 may include aproximal portion36, adistal portion38 and aconnector40 which structurally connectsproximal portion36 anddistal portion38 but allows them to rotate or otherwise move relative to each other to accommodate movement of the body joint circumscribed bybrace10. In the embodiment shown in FIG. 3,connector40 is a bicentric hinge of the sort disclosed in U.S. Pat. No. 4,697,583 to Mason, et. al., which is incorporated herein by this reference. Gears in such hinge permit only controlled rotation ofproximal portion36 relative to thedistal portion38, so thathorizontal axis42 ofconnector40 bisects the angle formed byproximal portion36 anddistal portion38.Connector40 may be a monocentric hinge, a non geared bicentric hinge, or any other linkage or structure which may be desired to accommodate movement of the body joint; it may, in cases where no movement is desired such as where thestiffener22 acts as a splint, simply be part of the structure of thestiffener22. Many such structures are conventional; for example,connector40 may be formed of portions ofproximal portion36 anddistal portion38, such as versions in which a combination of slots in such members cooperate with pins to allow movement of the portions relative to each other.
• FIGS.[0035]4-6 show abending tool44 for configuringstiffener22 to apply proper loading and unloading to a joint circumscribed bybrace10.Device44, whatever form it may take, seeks the result of allowing substantially permanent deformation of portions ofstiffener22 into a configuration which, when thestiffener22 is used in combination with the structures onbrace10, allows the joint circumscribed bybrace10 to receive loading and/or unloading forces of a magnitude and in a direction as desired for effective treatment or therapy. The term “substantially permanent deformation” means that when thestiffener22 as properly configured is used in combination withbrace10 to load and/or unload the joint, the bending of thestiffener22 in its spring like fashion to load and/or unload the joint will not cause the configuration of the stiffener22 (at normal temperatures encountered by the wearer) to creep or relax substantially to another shape such as, for instance, the shape it had before being deformed indevice44.
• Stiffener[0036]22 may be formed, for instance, of metal, or it may be formed of plastics or composite material. Metal stiffeners preferably feature a structure and modulus of elasticity which allow manual substantially permanent deformation. Manual bending is an acceptable form of substantially permanent deformation in such cases. For instance, and in general, causing proximal anddistal portions36 and38 respectively to be oriented more outwardly from the limb can be expected to causestiffener22 to impart greater unloading to the medial compartment of the knee shown in FIG. 1. By contrast, causing such portions to be oriented more inwardly toward the limb can be expected to causestiffener22 to impart greater unloading to the medial compartment of the knee shown in FIG. 1B.
• Stiffener[0037]22 formed of plastics or composite may be of a sort which can be heated prior to or during the bending operation, as by use of a hair dryer, hot liquid or other suitable application of heat. After configuration and deformation, upon return of temperature to that normally encountered by the wearer of braces such as these, the modulus of elasticity ofsuch stiffener22 increases to a point where thestiffener22 becomes spring-like rather than pliable or malleable so thatstiffener22 is thus able to impart loading and/or unloading to the joint circumscribed bybrace10.
• [0038]Device44 shown in FIG. 4 is one form of a device for substantially permanent deformation of the sort ofstiffener22 shown in FIG. 3 which features a bicentric hinge.Device44, which may be formed of metal, plastic or any other desired material, features abody46 with acavity48 adapted to receive theconnector40 and portions ofproximal portion36 anddistal portion38 ofstiffener22.Cavity48 walls define twofulcra50,50A against and about whichproximal portion36 anddistal portion38 ofstiffener22 may be controllably bent or deformed. FIG. 6 shows astiffener22 in combination withdevice44 for such substantially permanent deformation.
• FIGS. 5 and 6 show use of a goniometer for measuring the degree of bending or deformation of each of[0039]proximal portion36 anddistal portion38 ofstiffener22.Pins52 ondevice body46 receive grommets into thegoniometer56.Goniometer56 may be permanently or removably attached tobody46 using hook/loop fastener58 ongoniometer56 anddevice44. Any other desired fastener may be used, or no fastener at all.
• [0040]Device44 may assume any shape or configuration expedient for the result of controllably substantially permanently deforming portions of stiffener. Alternatively,device44 need not be used at all if not desired. A wearer or medical professional may simply bend or deform thestiffener22 at any point along its length using whatever implements are deemed appropriate in order to create a shape and configuration that is substantially permanent and that properly loads and/or unloads the joint circumscribed bybrace10.
• According to the embodiments shown in the Figures, the[0041]stiffener22 may be configured by substantially permanently deforming it indevice44 or as otherwise desired in order to apply proper loading/unloading to the joint being treated.Indicia60 and61 on thegoniometer56 may be employed for this purpose.Indicia60 may, but need not, appear on the central portion of thegoniometer56.Indicia61 appear onarms62. In practice, the clinician or qualified other person alignsarms62 ofgoniometer56 with the calf and thigh of the wearer's leg to be treated withbrace10 shown in FIG. 1; the position of thearms62 may be noted usingindicia60. While thearms62 ofgoniometer56 are maintained in this position on thegoniometer56, thegoniometer56 may then be placed ondevice44 for configuration ofstiffener22. As shown in FIG. 6, theproximal portion36 anddistal portion38 ofstiffener22 may be manually bent indevice44 to align with acenter index61 on eacharm62; the stiffener has thus been configured to correspond in shape to the geometry of the limb of the wearer to be treated.
• Stiffener[0042]22 may then be configured, or configured continuously as part of the process stated in the previous sentence, indevice44 to orientproximal portion36 anddistal portion38 as appropriate in order to load the joint properly. As shown in FIG. 7,indicia61 onarms62 ofgoniometer56 may be used for this purpose. Orientation ofportions36 and38 parallel to the zerodegree indicia61 results in neutral loading, since the stiffener is simply configured to the shape of the limb as reflected by thearms62 being set relative toindicia60 during the limb measuring steps mentioned above. Orientation ofportions36 and38 substantially parallel to the sixdegree loading indicia61 results in relatively large forces applied to the knee, while orientation substantially parallel to the three degree loading indicia results in relatively lighter forces applied to the knee.
• After configuration, the stiffener is attached to the[0043]brace10. Tensioningstructures30 are properly tensioned and fastened to apply tension toproximal portion20 anddistal portion21 of the limb while the central portions of thestiffener22 apply compressive forces to the joint in order to unload the side of joint opposite thestiffener22. In a brace with no straps,flap16 may be adjusted as desired to assist in this purpose. If thestiffener22 is permanently attached to brace10, it is configured by remaining withinbrace10. Patient comfort and clinician empirical inspection may be employed, among other techniques, which may or may not involve conventional measurement apparatus, to ensure that tensioningstructures30 andstiffener22 properly apply forces to load and/or unload the joint.
• The foregoing is provided for purposes of explanation and disclosure of preferred embodiments of the present invention. Modifications, additions and/or deletions may be made to the structures where their components shown and described in this document without departing from the scope or spirit of the invention.[0044]

Claims (7)

What is claimed is:

1. A method for loading a joint of a limb, the method comprising the steps of:

a. providing a joint brace, comprising:

(1) a sleeve adapted to circumscribe a proximal part of the limb, a distal part of the limb, and portions of the joint connection the proximal and distal parts of the limb;

(2) an adjustable stiffener removably attached to one side of the brace, the stiffener comprising:

i. a proximal portion;

ii. a distal portion;

iii. a connector allowing the proximal portion and distal portions to rotate relative to each other when the brace is installed on the wearer;

iv. the proximal and distal portions made of material which may be substantially permanently deformed in order to configure the stiffener to a shape adapted to allow the brace to load the joint as desired, but of sufficient stiffness to avoid substantial permanent deformation when the brace is loading the joint;

(3) a proximal tensioning structure adapted to apply tension to at least part of the proximal part of the limb and at least part of the proximal portion of the stiffener; and

(4) a distal tensioning structure adapted to apply tension to at least part of the distal part of the limb and at least part of the distal portion of the stiffener,

(5) the proximal tensioning structure, the distal tensioning structure and the stiffener adapted to cooperate to apply loading on the joint.

b. providing a device for configuring the joint brace, the device comprising:

(1) a body relative to which part of the stiffener may be placed, the body including a fulcrum about which a portion of the stiffener may be bent; and

(2) a goniometer attached to the body in the vicinity of the fulcrum for measuring the angle at which parts of the stiffener are bent relative to each other;

c. placing the stiffener relative to the body in a manner that allows the stiffener to be controllably bent;

d. bending the stiffener to a desired configuration using the goniometer to bend the stiffener for proper loading of the joint;

e. attaching the stiffener to the brace;

f. placing the brace on the limb of a wearer; and

g. ensuring the tensioning structures and the stiffener cause the brace to load the joint in a predetermined manner.

2. The method ofclaim 1 in which the joint to be loaded is a knee, the connector of the stiffener is bicentric and the body and goniometer of the device are configured to permit controllable bending of each portion of the stiffener, the method comprising the additional steps of:

a. bending each portion of the stiffener to desired shape using the goniometer in order to create a stiffener configuration that is adapted to treat compartmental osteoarthritis of the knee;

b. attaching the stiffener to the side of the brace opposite to the side of the knee on which loading is desired to be reduced;

c. ensuring that the tensioning structures apply tension properly to reduce the load on said side of the knee with a predetermined force in order to treat the compartmental osteoarthritis.

3. The method ofclaim 1 further comprising the step of recording angles from the goniometer at which the stiffener is bent.

4. The method ofclaim 1 further comprising the step of heating the stiffener to promote bending.

5. The method ofclaim 1 in which the brace further includes an inflatable condyle interposed between the joint and the stiffener, and further comprising the step of loading the knee by inflating the condyle.

6. A method for loading a joint of a limb, the method comprising the steps of:

a. providing a joint brace, comprising:

(1) a sleeve adapted to circumscribe a proximal part of the limb, a distal part of the limb, and portions of the joint connecting the proximal and distal parts of the limb;

(2) an adjustable stiffener removably attached to one side of the brace, the stiffener comprising:

i. a proximal portion;

ii. a distal portion;

iii. a connector allowing the proximal portion and distal portions to rotate relative to each other when the brace is installed on the wearer;

iv. the proximal and distal portions made of material which may be substantially permanently deformed in order to configure the stiffener to a shape adapted to allow the brace to load the joint as desired, but of sufficient stiffness to avoid substantial permanent deformation when the brace is loading the joint;

(3) the stiffener adapted to apply force on the joint which is counteracted by forces on other parts of the limb;

b. providing a device for configuring the joint brace, the device comprising:

(1) a body relative to which part of the stiffener may be placed, the body including a fulcrum about which a portion of the stiffener may be bent; and

(2) a goniometer attached to the body in the vicinity of the fulcrum for measuring the angle at which parts of the stiffener are bent relative to each other;

c. placing the stiffener relative to the body in a manner that allows the stiffener to be controllably bent;

d. bending the stiffener to a desired configuration using the goniometer to bend the stiffener for proper loading of the joint;

e. attaching the stiffener to the brace;

f. placing the brace on the limb of a wearer; and

g. ensuring the stiffener causes the brace to load the joint in a predetermined matter.

7. The method ofclaim 6 in which the joint to be loaded is a knee, the connector of the stiffener is bicentric and the body and goniometer of the device are configured to permit controllable bending of each portion of the stiffener, the method comprising the additional steps of:

a. bending each portion of the stiffener to a desired shape using the goniometer in order to create a stiffener configuration that is adapted to treat compartmental osteoarthritis of the knee;

b. attaching the stiffener to the brace and applying the brace to the leg; and;

c. ensuring that the stiffener loads the knee with a predetermined force in order to treat the compartmental osteoarthritis.

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