OA Bracing Clinical Guide

THE OSTEOARTHRITIC KNEE

THE CLINICAL STORY OF EFFECTIVENESS FOR OA KNEE BRACING

MANAGING OA OF THE KNEE WITH DONJOY®

FACTS & FIGURES Global prevalence of knee OA 4

OA BRACING AS A SOLUTION

= 654 MILLION OA PATIENTS in 40+ age group

WITH AGING populations and increasing rates of obesity and injury, the prevalence of osteoarthritis is expected to continue to increase.

MALALIGNMENT

ABERRANT BIOMECHANICS

INCREASED BODY WEIGHT

MUSCLE WEAKNESS

INCREASED COMPARTMENT LOADING

DECREASED ACTIVITY

DECREASED STABILITY

DECREASED CONFIDENCE

PAIN

DonJoy ® OA braces improve alignment 5,9,10,19,20,21

DonJoy OA braces reduce knee moments 5,9,10,19,21

DonJoy OA braces increase joint space 16,17

DonJoy OA braces relieve knee pain 5,6,8,17

DonJoy OA braces improve mobility and physical function 6,11

DonJoy ® OA braces improve confidence 9

DonJoy OA braces improve knee stability 9,10,12

22.9% of people ≥ 40 years suffer from knee OA

BRACES and other assistive technologies can help people with osteoarthritis to stay independent when movement becomes more difficult (WHO 2023 facts sheet 28 )

Push

Pull

DONJOY offers push or pull unloading technology options depending on the severity of the osteoarthritis, activity level, and other related needs of the patient.

RISK FACTORS

TREATMENT GAP Approximately 20% of American patients with symptomatic knee OA linger in what's called a "treatment gap" for 10 years. 14 During this treatment gap phase, unloader bracing is a cost-effective conservative treatment that can be utilized to aid in symptom relief. 13, 15

Gender 2,4

Aging 2,4

Malalignment 23,25

Muscle Weakness 18,22

Genetics 1,27

Previous Knee Injury/Trauma 24,26

Obesity 2,4

Knee Overload 2,3,28

INTRODUCING THE DONJOY ROAM™ OA ROAM REDUCED KNEE ADDUCTION ANGLES IN MAJORITY OF PATIENTS.

EFFECTIVENESS OF DONJOY ® OA BRACES

Increased Joint Space

ROAM IMPROVED LOAD ACCEPTANCE AFTER HEEL STRIKE WHICH IMPROVED THE FLEXION- EXTENSION PATTERN FROM EARLY TO MIDSTANCE PHASES. Healthier quadriceps use was suggested based on the increased flexion moments during the gait phase. The blue lines in the knee flexion graphs show that ROAM improved load acceptance after heel strike which improved the flexion-extension pattern from early to midstance phases.

DonJoy OA Defiance ® brace can induce a significant increase (0.3 mm) in medial compartment dynamic joint space during gait in medial compartment knee OA patients 17 .

Lower knee adduction angle led to a more balanced mediolateral load distribution. Blue line shows joint moment and joint angle changes when ROAM is worn versus the gray line representing when no brace is applied. As indicated in the blue line, ROAM reduced knee adduction angles in majority of patients. Lower knee adduction angle led to a more balanced mediolateral load distribution.

More red means narrower joint space

More green means increased joint space

JOINT MOMENT (EXTERNAL)

KNEE FLEXION (Flex +ve)

KNEE ADDUCTION (Add +ve)

Increased dynamic joint space during gait with DonJoy ® braces offloads the OA compartment 17

.29

1.2

0.11

0.8

–0.07

–0.5

–0.26

–0.2

Improved Alignment and Stability

–0.44

–0.1

0.0 25.0 50.0 75.0 100.0

0.0 25.0 50.0 75.0 100.0

• DonJoy ® OA braces effectively improve alignment by shifting the knee into a more valgus position in subjects with varus knees 5,20 as well as in normally aligned subjects 19 . • At approximately 10% of the gait, the point of greatest loading, the OA Adjuster brace produced the greatest corrective effect 20,21 • DonJoy ® OA braces reduce peak knee adduction moment up to 32% during gait 5,19,21 and stair stepping 29 .

JOINT ANGLES

KNEE FLEXION (Flex +ve)

KNEE ADDUCTION (Add +ve)

69.1

20.6

51.8

16.6

34.4

12.6

17.1

8.5

–0.3

4.5

0.0 25.0 50.0 75.0 100.0

0.0 25.0 50.0 75.0 100.0

DONJOY ROAM OA

No Brace JOINT

Pain Relief

THE OA TAKE-AWAY

• The DonJoy OA Adjuster ™ and OA Defiance ® lead to significant pain relief at rest and during activity and improve symptoms of stiffness and function 5,6,8,9,17 . • In a systematic review by Feehan et al. 7 including 15 clinical studies, 98.6% of 567 patients with medial knee OA experienced pain relief when fitted with an off-loading brace. • As shown below, both OTS and Custom DONJOY unloader braces significantly reduced pain and stiffness, with OA defiance significantly improving function when compared to no brace at all.

DONJOY Unloader bracing has been clinically proven to: • Improve alignment • Reduce knee moments • Increase joint space • Relieve pain • Improve mobility and physical function Unloader bracing may help patients who have documented: • Pain during weight bearing or ascending / descending stairs • Pronounced Varus or Valgus knee deformity • Previous Menisectomy • Excess/High BMI • Recent injury or surgery • Ambulatory with knee instability

No Brace

DonJoy OA Defiance

DonJoy OA Adjuster

1200

1000

800

600

400

200

0

Pain

Stiffness

Function

Graph shows pain, stiffness, and function components of the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) in patients with varus knee OA wearing, No Brace , DonJoy OA Defiance , and DonJoy OA Adjuster . Lower values indicate improvement.

A DonJoy® off-loading brace can significantly improve pain, resulting in a more active life and increased quality of life. 6

Increased Confidence and Activity

Brian Cole, MD interview on OA brace patient selection.

CMS knee orthoses guideline

• The DonJoy OA Adjuster ™ improves knee confidence and perceived stability in patients with post-traumatic knee OA after ACL reconstruction 9 . • A recent patient feedback study showed that a DonJoy OA Defiance ® brace increases the possibility to perform daily activities and also enables increased mobility away from the home environment, including going to a local shop, resulting in a more active life and increased quality of life 6 .

Enovis™ guarantees patient satisfaction with DONJOY OA Knee braces.

Patients/customers not completely satisfied with their DonJoy Knee Osteoarthritis Brace may receive credit or refund for the cost of the brace if our representative cannot fix your issue within 90 days from initial fitting.* Terms & conditions apply.

A DonJoy® off-loading brace can bring back freedom of movement to knee OA patients 6

* (Does not include custom fabricated braces, customer/patient pays cost for return shipping of the brace in order to be issued a credit.)

OA BRACING AS A SOLUTION

TRIZONE ® KNEE SLEEVE

OA REACTION WEB ®

ACTIVITY LEVEL

ACTIVITY LEVEL

DAILY ACTIVITIES

HIGH

DAILY ACTIVITIES

HIGH

DURATION OF WEAR

DURATION OF WEAR

DURING ACTIVITY

CONTINUOUS

DURING ACTIVITY

CONTINUOUS

RIGIDITY

RIGIDITY

FLEXIBLE

FIRM

FLEXIBLE

FIRM

* Not reimbursable by insurance

ACTIVITY LEVEL

ACTIVITY LEVEL

DAILY ACTIVITIES

HIGH

DAILY ACTIVITIES

HIGH

CLIMA-FLEX ® OA

OA NANO ™

DURATION OF WEAR

DURATION OF WEAR

DURING ACTIVITY

CONTINUOUS

DURING ACTIVITY

CONTINUOUS

RIGIDITY

RIGIDITY

FLEXIBLE

FIRM

FLEXIBLE

FIRM

ACTIVITY LEVEL

ACTIVITY LEVEL

DAILY ACTIVITIES

HIGH

DAILY ACTIVITIES

HIGH

OA FULLFORCE ™

ROAM ™ OA *

DURATION OF WEAR

DURATION OF WEAR

DURING ACTIVITY

CONTINUOUS

DURING ACTIVITY

CONTINUOUS

RIGIDITY

RIGIDITY

FLEXIBLE

FIRM

FIRM FLEXIBLE *Available in a custom option and off the shelf

ACTIVITY LEVEL

ACTIVITY LEVEL

CUSTOM OA DEFIANCE ®

DAILY ACTIVITIES

HIGH

DAILY ACTIVITIES

HIGH

OA ADJUSTER ™ 3

DURATION OF WEAR

DURATION OF WEAR

DURING ACTIVITY

CONTINUOUS

DURING ACTIVITY

CONTINUOUS

RIGIDITY

RIGIDITY

FLEXIBLE

FIRM

FLEXIBLE

FIRM

REFERENCES

NOTES

1. Arthritis Foundation. http://www.arthritis.org/ 2. Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. 3. Cameron KL, Hsiao MS, Owens BD, Burks R, Svoboda SJ. Incidence of physician-diagnosed osteoarthritis among active duty United States military service members. Arthritis Rheum. 2011 Oct;63(10):2974-82. 4. Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. 5. Draganich L, Reider B, Rimington T, Piotrowski G, Mallik K, Nasson S. The effectiveness of self-adjustable custom and off-the-shelf bracing in the treatment of varus gonarthrosis. J Bone Joint Surg Am. 2006 Dec;88(12):2645-52. 6. Dries T, VAN DER Windt JW, Akkerman W, Kluijtmans M, Janssen RPA. Effects of a semi-rigid knee brace on mobility and pain in people with knee osteoarthritis. J Rehabil Med Clin Commun. 2022 Jul 5;5:2483. 7. Feehan NL, Trexler GS, Barringer WJ. The Effectiveness of Off-Loading Knee Orthoses in the Reduction of Pain in Medial Compartment Knee Osteoarthritis: A Systematic Review. J Prosthet Orthot 2012;24(1):39-49. 8. Giori NJ. Load-shifting brace treatment for osteoarthritis of the knee: a minimum 2 1/2-year follow-up study. J Rehabil Res Dev. 2004 Mar;41(2):187-94. 9. Hart HF, Collins NJ, Ackland DC, Cowan SM, Hunt MA, Crossley KM. Immediate Effects of a Brace on Gait Biomechanics for Predominant Lateral Knee Osteoarthritis and Valgus Malalignment After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Apr;44(4):865-73. 10. Hart HF, Crossley KM, Collins NJ, Ackland DC. Bracing of the Reconstructed and Osteoarthritic Knee during High Dynamic Load Tasks. Med Sci Sports Exerc. 2017 Jun;49(6):1086-1096. 11. Khan M, Adili A, Winemaker M, Bhandari M. Management of osteoarthritis of the knee in younger patients. CMAJ. 2018 Jan 22;190(3):E72-E79. 12. Kwaees TA, Richards J, Rawlinson G, Charalambous CP, Chohan A. Can the use of proprioceptive knee braces have implications in the management of osteoarthritic knees: An exploratory study. Prosthet Orthot Int. 2019 Apr;43(2):140-147. 13. Lee PY, Winfield TG, Harris SR, Storey E, Chandratreya A. Unloading knee brace is a cost-effective method to bridge and delay surgery in unicompartmental knee arthritis. BMJ Open Sport Exerc Med. 2017 Feb 21;2(1):e000195. 14. London NJ, Miller LE, Block JE. Clinical and economic consequences of the treatment gap in knee osteoarthritis management. Med Hypotheses. 2011 Jun;76(6):887-92. 15. Mistry DA, Chandratreya A, Lee PYF. An Update on Unloading Knee Braces in the Treatment of Unicompartmental Knee Osteoarthritis from the Last 10 Years: A Literature Review. Surg J (N Y). 2018 Jul 2;4(3):e110-e118 16. Nadaud MC, Komistek RD, Mahfouz MR, Dennis DA, Anderle MR. In Vivo Three-Dimensional Determination of the Effectiveness of the Osteoarthritis Knee Brace: A Multiple Brace Analysis. J Bone Joint Surg Am. 2005;87 Suppl 2:114-9. 17. Nagai K, Yang S, Fu FH, Anderst W. Unloader knee brace increases medial compartment joint space during gait in knee osteoarthritis patients. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2354-2360. 18. Øiestad BE, Juhl CB, Culvenor AG, Berg B, Thorlund JB. Knee extensor muscle weakness is a risk factor for the development of knee osteoarthritis: an updated systematic review and meta-analysis including 46 819 men and women. Br J Sports Med. 2022 Mar;56(6):349-355. 19. Orishimo KF, Kremenic IJ, Lee SJ, McHugh MP, Nicholas SJ. Is valgus unloader bracing effective in normally aligned individuals: implications for post-surgical protocols following cartilage restoration procedures. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2661-6. 20. Richards J, Jones R, Kim W. Biomechanical changes in the conservative treatment of medial compartment osteoarthritis of the knee using valgus bracing. ICRS 2006 21. The Comprehensive Textbook of Clinical Biomechanics, 2nd Edition. Elsevier 2018. ISBN 9780702054891. 22. Segal NA, Glass NA. Is quadriceps muscle weakness a risk factor for incident or progressive knee osteoarthritis? Phys Sportsmed. 2011;39(4):44-50. 23. Sharma L, Song J, Felson DT, Cahue S, Shamiyeh E, Dunlop DD. The role of knee alignment in disease progression and functional decline in knee osteoarthritis.JAMA 2001;286:188–195. 24. Snoeker B, Turkiewicz A, Magnusson K, Frobell R, Yu D, Peat G, Englund M. Risk of knee osteoarthritis after different types of knee injuries in young adults: a population-based cohort study. Br J Sports Med. 2020 Jun;54(12):725-730. 25. Tanamas S, Hanna FS, Cicuttini FM, Wluka AE, Berry P, Urquhart DM. Does knee malalignment increase the risk of development and progression of knee osteoarthritis? A systematic review. Arthritis Rheum. 2009 Apr 15;61(4):459-67. 26. Webster KE, Hewett TE. Anterior Cruciate Ligament Injury and Knee Osteoarthritis: An Umbrella Systematic Review and Meta-analysis. Clin J Sport Med. 2022 Mar 1;32(2):145-152. 27. WHO July 2023 Osteoarthritis Key Facts https://www.who.int/news-room/fact-sheets/detail/osteoarthritis 28. Yucesoy B, Charles LE, Baker B, Burchfiel CM. Occupational and genetic risk factors for osteoarthritis: a review. Work. 2015 Jan 1;50(2):261-73. doi: 10.3233/WOR-131739. 29. Mont MA, Cherian JJ, Bhave A, Starr R, Elmallah RK, Beaver WB Jr, Harwin SF. Unloader Bracing for Knee Osteoarthritis: A Pilot Study of Gait and Function. Surg Technol Int. 2015 Nov;27:287-93.

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Individual results may vary. Neither DJO, LLC nor any of the Enovis companies dispense medical advice. The contents of this document do not constitute medical, legal, or any other type of professional advice. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.

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