Clinical UM Guideline

This document addresses the intended use of prefabricated functional or rehabilitation knee braces and prophylactic knee braces.

Note: Please refer to the following document for additional information concerning knee braces:

• CG-OR-PR-03 Custom-made Knee Braces

Medically Necessary:

Prefabricated functional or rehabilitation knee braces are considered medically necessary for individuals when any of the following criteria are met:

1. Documented anterior or posterior cruciate ligament tears or functional instability episodes due to cruciate ligament insufficiency when non-surgical treatment is elected; or
2. Grade II or III medial collateral or lateral collateral ligament sprain to support ambulation when the use of a hinged brace allows for controlled joint motion; or
3. Posterior cruciate or posterior lateral reconstruction, including reconstruction after knee dislocation; or
4. Recent surgery for anterior cruciate ligament repair in the post-operative recovery phase; or
5. Recent surgery for meniscal cartilage repair in the post-operative recovery phase; or
6. Major ligament and bony reconstruction above the knee such as patella or quadriceps tendon repair, medial and lateral collateral ligament repair; or
7. Major fractures requiring early post-injury or post-operative motion such as patella fractures or tibial plateau fractures; or
8. Osteoarthritis of the knee (unicompartmental) who meet any of the following:
   1. High tibial osteotomy or total knee arthroplasty (replacement) candidate that may elect non-surgical treatment; or
   2. To predict the success of high tibial osteotomy versus total knee arthroplasty; or
   3. Severe patellofemoral arthrosis in conjunction with medial or lateral compartment arthrosis.

Not Medically Necessary:

Prefabricated functional or rehabilitation knee braces are considered not medically necessary for individuals who are status post knee surgery when the criteria are not met, including, but not limited to total knee arthroplasty (unless there is documented ligament insufficiency).

Prefabricated functional or rehabilitation knee braces are considered not medically necessary for non-surgical indications when the criteria are not met.

Prophylactic knee braces are considered not medically necessary for all indications.

Note: Individuals with height (tall or short stature) or weight (obesity) variations can be fitted with a prefabricated (custom-fitted) knee brace with any of the following adjustments:

• extra-large straps for an obese person
• a pediatric model for a person of short stature
• extensions for an unusually tall person

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.

When services may be Medically Necessary when criteria are met for functional or rehabilitation braces:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met for functional or rehabilitation braces, or for situations designated in the Clinical Indications section as not medically necessary.

Prefabricated knee braces, also known as off-the-shelf knee braces, are manufactured in standard sizes and require only minimal adjustments. These braces are custom-fitted to the extent that the individual is fitted to a limited selection of sizes (that is, small, medium, large, extra-large) and only require measurements and a sizing chart for fitting. A prefabricated knee brace may be modified by an individual with expertise with minimal adjustments that have been assembled, bent, trimmed, molded, or otherwise customized to fit the specific person. A custom-fitted, prefabricated knee brace should not be confused with a custom-made knee brace.

The U.S. Food and Drug Administration (FDA) defines a brace as “device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.” Knee braces are classified as a Class 1 device by the FDA and are exempt from a premarket notification application (PMA) requirement prior to marketing any device.

Knee braces can be subdivided into four categories based on their intended use: prophylactic braces, rehabilitation braces, functional braces, and unloader knee braces. With the exception of unloader (custom-made) knee braces (see CG-OR-PR-03 Custom-made Knee Braces); these categories are defined as follows:

Prophylactic knee braces

Prophylactic braces are designed to prevent or reduce the severity of ligament injuries in a relatively normal (stable) knee. These injuries, primarily to the medial collateral ligament (MCL), are among the most common athletic knee injuries. There is a lack of evidence to support that the use of prophylactic braces reduces the incidence or severity of injuries of ligaments of the knee.

Rehabilitation knee braces

Rehabilitation braces are designed to allow protected and controlled motion of the injured knee treated operatively or non-operatively. These braces allow for controlled joint motion and typically consist of hinges that can be locked into place to limit range of motion. Rehabilitation braces are commonly used for 6 to 12 weeks following an injury. Rehabilitation braces are usually purchased prefabricated (off-the-shelf) and can be ordered either as small, medium, or large, or by a size chart. Most rehabilitation knee braces can be adjusted within each size to allow for edema or atrophy, and are not custom-made.

Functional knee braces

Functional braces are designed to assist or provide stability for the anterior cruciate ligament (ACL) or other ligament deficient knees, and provide protection for the ACL or other ligaments after knee repairs or reconstructions. 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. 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.

The American Academy of Orthopaedic Surgeons (AAOS) 2022 guidelines on the management of ACL injuries do not support the routine use of functional knee bracing following isolated ACL reconstruction, stating, “Functional knee braces are not recommended for routine use in patients who have received isolated primary ACL reconstruction, as they confer no clinical benefit”. This recommendation is limited, based on strong strength of evidence. They also state, “Prophylactic bracing is not a preferred option to prevent ACL injury,” citing low strength of evidence. Lowe (2017) published a systematic review evaluating the efficacy of functional knee braces following ACL reconstruction. The authors note that there is limited evidence supporting the use of functional bracing. No specific functional brace has been validated as a means of effectively reducing the risk of re-injury following ACL reconstruction. The authors note that further studies are needed to clarify the role of functional knee braces following ACL reconstruction. In another systematic review, Marois and colleagues (2021) investigated whether the use of a knee brace when returning to sports could prevent a second injury after ACL reconstruction. The authors noted that there were no trends indicating a protective effect of knee braces against retear after ACL reconstruction due to a limited amount of included studies (n=3) and heterogeneity in their methods and outcomes.

Functional knee braces have also been used in individuals with osteoarthritis in order to decrease the weight on painful joints. The 2021 AAOS guidelines on the management of osteoarthritis of the knee indicate that “brace treatment could be used to improve function, pain, and quality of life in patients with knee osteoarthritis” (moderate recommendation). Alfatafta and colleagues (2021) published a systematic review aimed at evaluating the effects of using a knee valgus brace on pain and activity levels in individuals with medial compartment knee osteoarthritis. They found that while using a knee valgus brace was effective at reducing pain and improving activity level, most studies evaluated the impact of the brace for less than 6 months. The authors note there is a need for further studies to evaluate the long-term impact of the knee valgus brace and the identification of individuals who would likely benefit from its use.

Table 1. Prefabricated (Off-the-shelf, Custom-fitted) Knee Braces (Not intended to be a complete list of devices.)

Peer Reviewed Publications:

1. Alfatafta H, Onchonga D, Alfatafta M, et al. Effect of using knee valgus brace on pain and activity level over different time intervals among patients with medial knee OA: systematic review. BMC Musculoskelet Disord. 2021; 22(1):687.
2. Andersson D, Samuelsson K, Karlsson J. Treatment of anterior cruciate ligament injuries with special reference to surgical technique and rehabilitation: an assessment of randomized controlled trials. Arthroscopy. 2009; 25(6):653-685.
3. Askenberger M, Bengtsson Moström E, Ekström W, et al. Operative repair of medial patellofemoral ligament injury versus knee brace in children with an acute first-time traumatic patellar dislocation: A randomized controlled trial. Am J Sports Med. 2018; 46(10):2328-2340.
4. 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.
5. Beynnon BD, Fleming BC, Churchill DL, Brown D. The effect of anterior cruciate ligament deficiency and functional bracing on translation of the tibia relative to the femur during non-weight bearing and weight bearing. Am J Sports Med. 2003; 31(1):99-105.
6. Birmingham TB, Bryant DM, Giffin JR, et al. A randomized controlled trial comparing the effectiveness of functional knee brace and neoprene sleeve use after anterior cruciate ligament reconstruction. Am J Sports Med. 2008; 36(4):648-655.
7. 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.
8. Chew KT, Lew HL, Date E, Fredericson M. Current evidence and clinical applications of therapeutic knee braces. Am J Phys Med Rehabil. 2007; 86(8):678-686.
9. DeVita P, Lassiter T, Hortobagyi T, Torry M. Functional knee brace effects during walking in patients with anterior cruciate ligament reconstruction. Am J Sports Med. 1998; 26(6):778-784.
10. Feller J, Bartlett J, Chapman S, Delahunt M. Use of an extension-assisting brace following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 1997; 5(1):6-9.
11. Fitzgerald GK, Axe MJ, Snyder-Mackler L. Proposed practice guidelines for nonoperative anterior cruciate ligament rehabilitation of physically active individuals. J Orthop Sports Phys Ther. 2000; 30(4):194-203.
12. Giotis D, Zampeli F, Pappas E, et al. The effect of knee braces on tibial rotation in anterior cruciate ligament-deficient knees during high-demand athletic activities. Clin J Sport Med. 2013; 23(4):287-292.
13. Harilainen A, Sandelin J. Post-operative use of knee brace in reconstruction: 5-year follow-up results of a randomized prospective study. Scand J Med Sci Sports. 2006; 16(1):14-18.
14. Harilainen A, Sandelin J, Vanhanen I, et al. Knee brace after bone-tendon-bone anterior cruciate ligament reconstruction. Randomized, prospective study with 2-year follow-up. Knee Surg Sports Traumatol Arthrosc. 1997; 5(1):10-13.
15. Jacobi M, Reischl N, Wahl P, et al. Acute isolated injury of the posterior cruciate ligament treated by a dynamic anterior drawer brace: a preliminary report. J Bone Joint Surg Br. 2010; 92(10):1381-1384.
16. Kartus J, Stener S, Kohler K, et al. Is bracing after anterior cruciate ligament reconstruction necessary? A 2-year follow-up of 78 consecutive patients rehabilitated with or without a brace. Knee Surg Sports Traumatol Arthrosc. 1997; 5(3):157-161.
17. Kellgren JH, Jeffrey M, Ball J. Atlas of standard radiographs. Oxford: Blackwell Scientific. 1963; 2.
18. Kirkley A, Webster-Bogaert S, Litchfield R, et al. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am. 1999; 81(4):539-548.
19. Lowe WR, Warth RJ, Davis EP, Bailey L. Functional Bracing After Anterior Cruciate Ligament Reconstruction: A Systematic Review. J Am Acad Orthop Surg. 2017; 25(3):239-249.
20. Maak TG, Marx RG, Wickiewicz TL. Management of chronic tibial subluxation in the multiple-ligament injured knee. Sports Med Arthrosc. 2011; 19(2):147-152.
21. Marois B, Tan XW, Pauyo T, et al. Can a knee brace prevent ACL reinjury: a systematic review. Int J Environ Res Public Health. 2021; 18(14):7611.
22. Matsuno H, Kadowaki KM, Tsuji H. Generation II knee bracing for severe medial compartment osteoarthritis of the knee. Arch Phys Med Rehabil. 1997; 78(7):745-749.
23. McDevitt ER, Taylor DC, Miller MD, et al. Functional bracing after anterior cruciate ligament reconstruction: a prospective, randomized, multicenter study. Am J Sports Med. 2004; 32(8):1887-1892.
24. Moyer RF, Birmingham TB, Bryant DM, et al. Biomechanical effects of valgus knee bracing: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015; 23(2):178-188.
25. Muellner T, Alacamlioglu Y, Nikolic A, Schabus R. No benefit of bracing on the early outcome after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 1998; 6(2):88-92.
26. Paluska S., McKeag D. Knee braces: current evidence and clinical recommendations for their use. Am Fam Physician. 2000; 61(2):411-418, 423-424.
27. Raja K, Dewan N. Efficacy of knee braces and foot orthoses in conservative management of knee osteoarthritis: a systematic review. Am J Phys Med Rehabil. 2011; 90(3):247-262.
28. Rannou F, Poiraudeau S, Beaudreuil J. Role of bracing in the management of knee osteoarthritis. Curr Opin Rheumatol. 2010; 22(2):218-222.
29. Risberg MA, Beynnon BD, Peura GD, Uh BS. Proprioception after anterior cruciate ligament reconstruction with and without bracing. Knee Surg Sports Traumatol Arthrosc. 1999; 7(5):303-309.
30. Risberg MA, Holm I, Steen H, et al. The effect of knee bracing after anterior cruciate ligament reconstruction. A prospective, randomized study with two years’ follow-up. Am J Sports Med. 1999; 27(1):76-83.
31. Vadalá A, Iorio R, DeCarli A, et al. The effect of accelerated, brace free, rehabilitation on bone tunnel enlargement after ACL reconstruction using hamstring tendons: a CT study. Knee Surg Sports Traumatol Arthrosc. 2007; 15(4):365-371.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Orthopaedic Surgeons (AAOS). Management of anterior cruciate ligament injuries. August 22, 2022. Available at: https://www.orthoguidelines.org/topic?id=1042&tab=all_guidelines. Accessed on December 15, 2023.
2. American Academy of Orthopaedic Surgeons (AAOS). Management of osteoarthritis of the knee (non-arthroplasty). August 31, 2021. https://www.aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-knee/oak3cpg.pdf. Accessed on December 15, 2023.
3. Duivenvoorden T, Brouwer RW, van Raaij TM, et al. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev. 2015;(3):CD004020.
4. Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020; 72(2):220-233.
5. Yeung SS, Yeung EW, Gillespie LD. Interventions for preventing lower limb soft-tissue running injuries. Cochrane Database Syst Rev. 2011;(7):CD001256.
6. U.S. Food and Drug Administration (FDA). CFR – Code of Federal Regulations Title 21. Current as of February 8, 2023. Available at: https://www.ecfr.gov/cgi-bin/text-idx?SID=b605863996f45e7e5675f4d69a8a9f26&mc=true&tpl=/ecfrbrowse/Title21/21cfr890_main_02.tpl. Accessed on December 15, 2023.

Functional Knee Braces
Prophylactic Knee Braces
Rehabilitation Knee Braces

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.