This document addresses the intended use of custom-made (i.e. custom fabricated, custom molded) functional and unloader knee braces.

Note: Please see the following related document for additional information concerning knee braces:

• CG-OR-PR-02 Prefabricated and Prophylactic Knee Braces

MedicallyNecessary:

Custom-made (custom fabricated, custom molded) unloader knee braces are considered medically necessary as an alternative to a prefabricated (custom-fitted) knee brace for the treatment of unicompartmental osteoarthritis with or without valgus/varus deformity, when any of the following criteria are met:

• Individual is a candidate for high tibial osteotomy or total knee arthroplasty (replacement) and may elect non-surgical treatment; or
• To predict the success of high tibial osteotomy versus total knee arthroplasty; or
• Individual has severe patellofemoral arthrosis in conjunction with medial or lateral compartment arthrosis.

Custom-made (custom fabricated, custom molded) functional knee braces may be medically necessary as an alternative to a prefabricated (custom-fitted) knee brace when the individual meets any of the following criteria, including but not limited to:

• Abnormal limb contour (disproportionate size of thigh and calf); or
• Knee deformity that interferes with fitting (valgus or varus limb); or
• Minimal muscle mass upon which to suspend an orthosis.

Not Medically Necessary:

Custom-made (custom molded, custom fabricated) knee braces, functional or unloader, are considered not medically necessary when the above criteria are not met.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

*Note: The code L1844 may be used either for a medically necessary custom-made unloader knee brace (only considered medically necessary in members with osteoarthritis) or it may be used to describe either a non-covered custom-made functional or rehabilitation (used in a postoperative setting) knee brace.

Knee braces can be subdivided into four categories based on their intended use. One category of braces, unloader knee braces, is specifically designed to "provide pain relief in arthritic knees." Unloader knee braces, also referred to as offloader knee braces are typically custom-made (custom fabricated, custom molded) and are considered for individuals who are unable to be fitted with a prefabricated (off-the-shelf) knee brace.  

Individuals with osteoarthritis of the knee with varus or valgus deformity often develop increased pain in the affected compartment due to increased mechanical loading. Unloader knee braces are designed and constructed to reduce this asymmetric loading in such knees. In order to decrease the weight on a painful knee joint, an unloader knee brace is designed to provide stability during activities of daily living. There is strong biomechanical data demonstrating reduction in adduction movement in varus knees when the appropriate unloader brace is used. Clinical studies have shown improvement in pain and function in individuals with medial compartment osteoarthritis using an unloader knee brace.

Functional knee braces are defined as braces designed to assist or provide stability for the ACL or other ligament deficient knees, and provide protection for the ACL or other ligaments after knee repairs or reconstructions. Derotation braces are typically used after injuries to ligaments and have medial and lateral bars with varying hinge and strap designs. These derotation braces are designed to permit significant motion and speed; in many instances, the braces are worn only during elective activities, such as sports. Braces made of graphite, titanium, or other lightweight materials are specifically designed for high-performance sports. Functional knee braces have also been used in individuals with osteoarthritis in order to decrease the weight on painful joints. Functional knee braces are worn throughout the day for unstable knees during activities of daily living or sports and may be either prefabricated (off-the-shelf) or custom-made. Custom-made functional knee braces may be prescribed as an alternative to a prefabricated, custom-fitted knee brace when an individual has a deformity of the knee or leg that interferes with fitting, such as a disproportionate thigh and calf; or minimal muscle mass upon which to suspend an orthosis. Height (exceptionally tall or short stature) or weight (obesity) alone are insufficient reasons for a custom-made functional knee brace. These individuals can be fitted with a prefabricated (custom-fitted) knee brace with the following adjustments: extensions for an unusually tall person, a pediatric model for a person of short stature, or extra large straps for an obese person.

Custom-made (custom molded, custom fabricated) unloader knee braces are fabricated specifically for an individual starting with basic materials, including, but not limited to, plastic, metal, leather, or cloth in the form of sheets or bars. Fabrication involves substantial work such as cutting, bending, molding, or sewing and may involve the incorporation of some prefabricated components. Constructing a custom-made knee brace involves more than trimming, bending, or other modifications to a substantially prefabricated item. A molded-to-member-model orthosis is a particular type of custom-made orthosis in which an impression of the specific body part is made by means of a plaster cast or CAD-CAM technology. This impression is then used to make a positive model of plaster or other material of the body part. The orthosis is then molded on this positive model.

Different radiographic grading systems have been used to classify the degree of osteoarthritis of the knee joint in symptomatic individuals. The Ahlbäck classification and Kellgren and Lawrence grading systems outlined in Table 1. are used to describe the severity of articular cartilage changes associated with osteoarthritis. These grading systems can be used to determine if an individual with osteoarthritis is a candidate for a knee brace.

Table 1. The Ahlbäck classification of radiographic knee OA of the tibiofemoral joint and the Kellgren and Lawrence grading system (Ahlbäck S, 1968; Kellgren JH, 1963)

Table 2. Custom-made Knee Braces

Cartilage: A cellular tissue in adults that is specific to joints. A tough, fibrous material with high collagen content, such as found in the meniscus of the knee.

Instability: Looseness, unsteadiness, or an inability to withstand normal physiologic loading without mechanical deformation.

Knee brace: A limb orthosis or device intended for medical purposes that is worn on the lower extremity to support, to correct, or to prevent deformities, or to align body structures for functional improvement.

Ligament: A collagenous tissue that connects two bones to stabilize a joint.

Meniscus: A soft-tissue structure that lines some joints and provides load distribution, shock absorption, and lubrication.

Osteoarthritis (OA): A deterioration of the weight bearing surface distinguished by destruction of the hyaline cartilage and narrowing at the joint space.

Osteotomy: A surgical procedure in which bone is cut and realigned.

Unicompartmental osteoarthritis of the knee: A condition characterized by degenerative articular cartilage in the medial or lateral aspect of the tibiofemoral joint; may be associated with meniscal disruption, ligamentous instability, and malalignment.

Valgus deformity: Angulation of a distal bone away from the midline in relation to its proximal partner; also referred to as "bow-legged."

Varus deformity: Angulation of a distal bone toward the midline in relation to its proximal partner; also referred to as "knock-kneed."

Peer Reviewed Publications:

1. Ahlbäck S. Osteoarthrosis of the knee: a radiographic investigation. Acta Radiol Stockholm. 1968; (suppl 277):7-72.
2. Beaudreuil J, Bendaya S, Faucher M, et al. Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee braces in knee osteoarthritis. Joint Bone Spine. 2009; 76(6):629-636.
3. Brouwer RW, van Raaij TM, Verharr JA, et al. Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial. Osteoarthritis Cartilage. 2006; 14(8):777-783.
4. Draper, ER, Cable, JM, Sanchez-Ballester, J, et al. Improvement in function after valgus bracing of the knee. An analysis of gait symmetry. J Bone Joint Surg Br. 2000; 82:1001.
5. Finger S, Paulos LE. Clinical and biomechanical evaluation of the unloading brace. J Knee Surg. 2002; 15(3): 155-158, discussion 159.
6. Iorio R, Healy WL. Unicompartmental arthritis of the knee. J Bone Joint Surg Am. 2003; 85(7):1351-1364.
7. Kellgren JH, Jeffrey M, Ball J. Atlas of standard radiographs. Oxford: Blackwell Scientific. 1963; 2.
8. Paluska S, McKeag D. Knee braces: current evidence and clinical recommendations for their use. Am Fam Med. 2000; 61(2):411-418, 423-424.
9. Rannou F, Poiraudeau S, Beaudreuil J. Role of bracing in the management of knee osteoarthritis. Curr Opin Rheumatol. 2010; 22(2):218-222.
10. van Raaij TM, Reijman M, Brouwer RW, et al. Medial knee osteoarthritis treated by insoles or braces: a randomized trial. Clin Orthop Relat Res. 2010; 468(7):1926-1932.
11. Warden SJ, Hinman RS, Watson MA Jr, et al. Patellar taping and bracing for the treatment of chronic knee pain: a systematic review and meta-analysis. Arthritis Rheum. 2008; 59(1):73-83.
12. Wright, FW, Fetzer, GB. Bracing after ACL reconstruction: a systematic review. Clin Orthop Relat Res. 2007; 455:162-168.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Orthopaedic Surgeons (AAOS). Guideline on the treatment of osteoarthritis of the knee (non-arthroplasty). December 6, 2008. Available at: http://www.aaos.org/Research/guidelines/guide.asp. Accessed on March 22, 2011.
2. Brouwer RW, Jakma TS, Verhagen AP, et al. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev. 2005; (1):CD004020. 

Custom Fabricated Knee Brace
Custom-made Functional Knee Brace
Custom-made Knee Brace
Custom molded Knee Brace
Offloader Knee Brace
Unloader Knee Brace

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.