OA Bracing Clinical Evidence Brochure

DONJOY ® OA BRACES

CLINICALLY-PROVEN EFFECTIVENESS OF KNEE OA BRACING

THE EVIDENCE

FACTS & FIGURES Global prevalence of knee OA 9 22.9%

= 654 MILLION OA PATIENTS in 40+ age group

of people ≥ 40 years suffer from knee OA

HIGHEST PREVALENCE IN ASIA 1.69 times more knee OA in Asia than in Europe and North America

LOWEST PREVALENCE

IN LATIN AMERICA

28.7% radiographic knee OA (all ages) 12.4% symptomatic knee OA (all ages)

Possible explanation: radiographic knee OA may be detected earlier, which can provide more opportunities for prevention.

344 MILLION people living with osteoarthritis (all joints) experience severity levels (moderate or severe) that could benefit from rehabilitation (WHO 2023 facts sheet 48 )

BRACES and other assistive technologies can help people with osteoarthritis to stay independent when movement becomes more difficult (WHO 2023 facts sheet 48 )

RISK FACTORS

MALALIGNMENT 41,44

GENDER 5,9

GENETICS 2,48

KNEE OVERLOAD 5,7,45,49

OBESITY 5,9

AGING 5,9

PREVIOUS KNEE INJURY 43,47

MUSCLE WEAKNESS 34,40

Fig. 1: Risk factors for knee OA

TREATMENT GAP

• The treatment gap is the time from unsuccessful exhaustion of conservative treatment to surgical intervention. During this treatment gap chronic pain and disability are endured by the patients and substantial economic resources are depleted 27,28 . • London et al. calculated that approximately 20% of American patients with symptomatic knee OA linger in this treatment gap for 10 years. For younger patients, this can extend to 20 years 28 , and the clinical scenario can be challenging because they often seek to remain involved in sporting activities. 21 • The off-loading knee brace is a cost-effective method as a bridging therapy and its long-term use can delay and reduce surgical intervention 26,29 . • A study by Lee et al. (2017) showed that patients who wore an off-loading knee brace for 2 years or more did not require surgery at 8 years follow-up 26 .

18m

16m

20% Treatment Gap

Difficulty with Ambulation

14m

12m

10m

8m 6m

Normal Ambulation

Knee Arthroplasties & HTOs

13.9m 3.6m 0.5m

Treatment Gap

Conservative Treatments

Fig. 2: The Treatment Gap 28

PROGRESSION OF KNEE OA AND HOW A DONJOY ® OA BRACE CAN HELP

MALALIGNMENT

ABERRANT BIOMECHANICS

INCREASED BODY WEIGHT

INCREASED COMPARTMENT LOADING

DECREASED ACTIVITY

PAIN

DonJoy ® OA braces improve alignment 10,17,35,37,38

DonJoy OA braces reduce knee moments 10,16,17,35,38

DonJoy OA braces increase joint space 31,32

DonJoy OA braces relieve knee pain 10,11,15,32

DonJoy OA braces improve mobility and physical function 11,21

Fig. 3: The progression of knee OA

In the conservative treatment modalities, analgesia and non-steroidal anti-inflammatory (NSAIDs) drugs provide reductions in pain, increased quality of life and increased activity levels. However, they don’t address the underlying biomechanical causes and consequences of the OA disease process. There are reports of increased joint loading 39 and accelerated disease progression 18 probably due to increased pain free activity or walking speed. Off-loading braces allow for a more active lifestyle while protecting the knee joint from excessive loading. A DONJOY OFF-LOADING BRACE CAN HELP KEEP THE PATIENT IN MOTION WHILE PROTECTING THE KNEE JOINT FROM EXCESSIVE LOADING

MUSCLE WEAKNESS

DECREASED STABILITY

DECREASED CONFIDENCE

DonJoy ® OA braces improve confidence 16

DonJoy OA braces improve knee stability 16,17,25

EFFECTIVENESS OF DONJOY ® OA BRACES

Increased joint space

MALALIGNMENT

ABERRANT BIOMECHANICS

INCREASED BODY WEIGHT

MUSCLE WEAKNESS

INCREASED COMPARTMENT LOADING

DECREASED ACTIVITY

DECREASED STABILITY

DECREASED CONFIDENCE

PAIN

• 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 32 . This corresponds to roughly 10% increase in joint space during the impact phase of gait. • The study measured the dynamic joint space in the medial compartment continuously over the stance phase of the gait using highly accurate biplane radiography system with three-dimensional sub-millimeter accuracy. The increase of medial compartment joint space when wearing the brace was consistent from heel strike to terminal stance in this study. (fig. 4)

More red means narrower joint space

More green means increased joint space

Joint space color coding

Fig 4: The instantaneous dynamic joint space during gait at 15% of the gait cycle for one subject. Subchondral bone surfaces are color coded according to minimum distance from the opposing bone surface. The figure demonstrates increased medial compartment joint space in the braced condition (red color disappeared, yellow surface decreased, green surface increased) 32 .

Increased dynamic joint space during gait with DonJoy ® braces offloads the OA compartment 32

Improved alignment and stability

MALALIGNMENT

ABERRANT BIOMECHANICS

INCREASED BODY WEIGHT

MUSCLE WEAKNESS

INCREASED COMPARTMENT LOADING

DECREASED ACTIVITY

DECREASED STABILITY

DECREASED CONFIDENCE

PAIN

• DonJoy ® OA braces effectively improve alignment by shifting the knee into a more valgus position in subjects with varus knees 10,37 as well as in normally aligned subjects 35 . • At approximately 10% of the gait, the point of greatest loading, the OA Adjuster brace produced the greatest corrective effect 37,38 (fig. 5). • In ACL reconstructed subjects with valgus malalignment and lateral compartment OA, a DonJoy OA brace not only reduces the knee abduction angle (fig. 6), but also tibial internal rotation angles during high dynamic loading activities 17 .

Time (s)

8 7

0.2

0.4

0.6

0.8

1.0

Adduction 0

6 5 4 3 2 1 0 1 3 5 7 9 11 13151719212325272931333537394143454749 Valgus brace No treatment Less varus in braced condition

Less valgus in braced condition

-2

-4 -6

-8

Abduction -10

Adjusted brace Unadjusted brace No brace

% Gait cycle

Fig. 5 : Varus angle from 0 to 50% of the gait cycle in subjects with varus malalignment. The greatest effect in the varus angle is during loading response from 0 to 20% of the gait cycle. At approximately 10% of the gait cycle, the difference between the braced and unbraced conditions was 4°. This was with a 5° dial-in of the OA Adjuster brace 31 . (Figure with courtesy of Jim Richards 38 ).

Fig. 6 : Frontal plane kinematics for no brace, unadjusted and adjusted brace conditions during hopping in subjects with valgus malalignment 17 .

EFFECTIVENESS OF DONJOY ® OA BRACES

Reduced knee adduction moment and adduction impulse

MALALIGNMENT

ABERRANT BIOMECHANICS

INCREASED BODY WEIGHT

MUSCLE WEAKNESS

INCREASED COMPARTMENT LOADING

DECREASED ACTIVITY

DECREASED STABILITY

DECREASED CONFIDENCE

PAIN

• The knee adduction moment during walking forces the knee outwards (varus) and creates compression on the medial side of the knee joint. The first peak adduction moment happens during loading, the second peak adduction moment happens during push off. • DonJoy ® OA braces reduce peak knee adduction moment up to 32% during gait 10,35,38 and stair stepping 30 . • The more the hinge is dialed in, the greater the reduction of the knee adduction moment 35 .

1st Peak Add Moment

2nd Peak Add Moment

0.8

29% Adduction Moment Decrease

0.6

32% Adduction moment decrease

0.4

0.2

No Brace

Neutral Dial-in

Max Dial-in

No Brace

Neutral Dial-in

Max Dial-in

Fig. 7: Changes in first (blue bars) and second (green bars) peak knee adduction moments during gait in normally aligned subjects wearing the OA Adjuster brace with multiple hinge dial-in conditions 35 . Dial-in of the hinge produced reduction of the peak knee adduction moments.

• The adduction angular impulse is a complimentary measure of knee joint loading and accounts for both the load as well as the loading time. If a person walks more slowly, the peak adduction moment may be lower but the adduction impulse may be higher as the loading time will be longer. • The DonJoy OA Adjuster ™ reduces the adduction impulse up to 37% 35 . • The more the hinge is dialed in, the greater the reduction of the knee adduction impulse 35 .

0.3

Fig. 8: Changes in knee adduction impulse by brace status. Knee adduction impulse was significantly decreased by 37% when wearing the OA Adjuster in the maximal tension condition compared with the no brace condition 35 .

0.2

37% Adduction Impulse Decrease

0.1

No Brace

Neutral Dial-in

Max Dial-in

Pain relief

MALALIGNMENT

ABERRANT BIOMECHANICS

INCREASED BODY WEIGHT

MUSCLE WEAKNESS

INCREASED COMPARTMENT LOADING

DECREASED ACTIVITY

DECREASED STABILITY

DECREASED CONFIDENCE

PAIN

• The DonJoy OA Adjuster ™ and OA Defiance ® lead to significant pain relief at rest and during activity and improve symptoms of stiffness and function 10,15,11,32,16 . • In a systematic review by Feehan et al. 12 including 15 clinical studies, 98.6% of 567 patients with medial knee OA experienced pain relief when fitted with an off-loading brace.

Baseline Custom Off-the-shelf

1200

1000

800

600

400

200

Pain

Stiffness

Function

Fig. 9: Graph showing the pain, stiffness and function components of the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) in patients with varus gonarthrosis wearing no brace , the (custom) DonJoy OA Defiance and DonJoy OA Adjuster brace. The values are given as the mean, and the bars indicate the standard deviation. Lower values indicate improvement. Both braces significantly reduced pain and stiffness. OA Defiance also significantly improved function 10 .

A DonJoy ® off-loading brace can significantly improve pain, resulting in a more active life and increased quality of life. 11

Increased confidence and activity

MALALIGNMENT

ABERRANT BIOMECHANICS

INCREASED BODY WEIGHT

MUSCLE WEAKNESS

INCREASED COMPARTMENT LOADING

DECREASED ACTIVITY

DECREASED STABILITY

DECREASED CONFIDENCE

PAIN

• The DonJoy OA Adjuster ™ improves knee confidence and perceived stability in patients with post-traumatic knee OA after ACL reconstruction 16 . • 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 11 .

More unbraced patients in the activities with less mobility

More braced patients in the activities with higher mobility

Mobility change

I no longer have a mobility restriction in terms of distance (> 5km)

I can walk in the house (0-10 meters)

I can walk to the neighbors (10-50 meters)

I can walk to the corner of the street (50-200 meters)

I can walk to the store etc. Nearby (200-1000 meters)

I can take a long walk continuously (1000-5000 meters)

Mobility without a knee brace Mobility with a knee brace

Fig. 10: Results for the question: “Please indicate how mobile you are with/without the knee brace?” 11 .

This figure shows the results regarding the change in mobility for all respondents. Mobility while using a knee brace improved considerably in different mobility groups. The mobility of respondents who were limited to their home environment reduced by 74%. The mobility of the respondents who were able to walk to a nearby shop increased by 50%, and the group experiencing no mobility restrictions increased from 3% without using a knee brace to 13% while using a knee brace. A total of 42% of respondents using a knee brace indicated that they could take a long walk again (18%) or go to the local shop (24%).

A DonJoy ® off-loading brace can bring back freedom of movement to knee OA patients 11

GUIDELINES AND RECOMMENDATIONS

• This evidence based practice guideline 6 is based on a systematic review of published studies for the non-arthroplasty treatment of osteoarthritis of the knee in adults (ages 17 years and older). The purpose of this clinical practice guideline is to evaluate current best evidence associated with treatment. • The strength of recommendation is assigned based on the quality of the supporting evidence, and also takes into account the quality, quantity, trade-offs between the benefits and harms of a treatment, and magnitude of a treatment’s effect.

"Brace treatment could be used to improve function, pain, and quality of life in patients with knee osteoarthritis."

STRENGTH OF RECOMMENDATION: MODERATE • Moderate means: Evidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. Also requires no or only minor concerns addressed in the EtD (Evidence to Decision) framework.

NON-PHARMACOLOGICAL

PHARMACOLOGICAL

INTRA-ARTICULAR

SURGICAL

Intra-articular corticosteroids

• • • •

Topical NSAID

Partial Meniscectomy

Supervised exercise

• • • •

Self-management

Oral NSAID

Platelet-rich plasma

Tibial Osteotomy

Free Floating Interpositional Devices • • • •

• • • •

Patient education

Oral Acetaminophen

Hyaluronic Acid

Arthroscopic Lavage/ Debridement

• • • •

BRACES

Dietary suppl

• • • •

Canes

Oral Narcotics

Neuromuscular training

• • • •

Weight loss

• • • •

Manual Therapy

• • • •

Massage

• • • •

Laser Treatment

• • • •

Acupuncture

• • • •

TENS

• • • •

PENS

Shock Wave Therapy

• • • •

Denervation Therapy

• • • •

Dry Needling

• • • •

Lat. wedge insoles

Fig. 11: AAOS Recommendations for the management of knee OA 6 .

• RECOMMENDATION FOR THE INTERVENTION • RECOMMENDATION AGAINST THE INTERVENTION

These 2019 ACR/AF recommendations 22 for the management of OA are based on the best available evidence of benefit, safety, and tolerability of physical, educational, behavioral, psychosocial, mind-body, and pharmacologic interventions, as well as the consensus judgment of clinical experts. Either strong or conditional recommendations were made for or against the approaches evaluated. • Tibiofemoral knee braces are strongly recommended for patients with knee OA in whom disease in 1 or both knees is causing a sufficiently large impact on ambulation, joint stability, or pain to warrant use of an assistive device, and who are able to tolerate the associated inconvenience and burden associated with bracing. • Patellofemoral braces are conditionally recommended for patients with patellofemoral knee OA in whom disease in 1 or both knees is causing a sufficiently large impact on ambulation, joint stability, or pain to warrant use of an assistive device. The recommendation is conditional due to the variability in results across published trials and the difficulty some patients will have in tolerating the inconvenience and burden of these braces.

NICE 33 does not recommend the routine use of braces, however they do recommend braces in specific conditions which are often present in knee OA patients:

"Do not routinely offer insoles, braces, tape, splints or supports to people with osteoarthritis unless: • there is joint instability or abnormal biomechanical loading and • therapeutic exercise is ineffective or unsuitable without the addition of an aid or device and • the addition of an aid or device is likely to improve movement and function".

REFERENCES

1. Andriacchi TP. Dynamics of knee malalignment. Orthop Clin North Am. 1994 Jul;25(3):395-403. PMID: 8028883. 2. Arthritis Foundation. http://www.arthritis.org/ 3. Baliunas AJ1, Hurwitz DE, Ryals AB, Karrar A, Case JP, Block JA, Andriacchi TP. Increased knee joint loads during walking are present in subjects with knee osteoarthritis. Osteoarthritis Cartilage. 2002 Jul;10(7):573-9. 4. Beynnon BD, Johnson RJ, Fleming BC, Peura GD, Renstrom PA, Nichols CE, Pope MH. The Effect of Functional Knee Bracing on the Anterior Cruciate Ligament in the Weightbearing and Nonweightbearing knee. Am J Sports Med 1997;25(3):353-9. 5. 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. 6. Brophy RH, Fillingham YA. AAOS Clinical Practice Guideline Summary: Management of Osteoarthritis of the Knee (Nonarthroplasty), Third Edition. J Am Acad Orthop Surg. 2022 May 1;30(9):e721-e729. 7. 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. 8. Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. 9. 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. 10. 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. 11. 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. 12. 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. 13. Fleming BC, Renstrom PA, Beynnon BD, Engstrom B, Peura G. The influence of functional knee bracing on the anterior cruciate ligament strain biomechanics in weightbearing and nonweightbearing knees. Am J Sports Med 2000;28(6):815-24. 14. Foroughi N, Smith RM, Lange AK, Baker MK, Fiatarone Singh MA, Vanwanseele B. Dynamic alignment and its association with knee adduction moment in medial knee osteoarthritis. Knee. 2010 Jun;17(3):210-6. 15. 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. 16. 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. 17. 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. 18. Huskisson EC, Berry H, Gishen P, Jubb RW, Whitehead J. Effects of antiinflammatory drugs on the progression of osteoarthritis of the knee. LINK Study Group. Longitudinal investigation of non-steroidal anti-inflammatory drugs in knee osteoarthritis. Journal of Rheumatology 1995;22:1941–6. 19. Johnson F, Leitl S, Waugh W. The distribution of load across the knee. A comparison of static and dynamic measurements. J Bone Joint Surg Br. 1980 Aug;62(3):346-9. 20. Khan SJ, Khan SS, Usman J, Mokhtar AH, Abu Osman NA. Orthoses versus gait retraining: Immediate response in improving physical performance measures in healthy and medial knee osteoarthritic adults. Proc Inst Mech Eng H. 2020 Jul;234(7):749-757. 21. 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. 22. Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/ Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Feb;72(2):149-162. 23. Kraus VB, Sprow K, Powell KE, Buchner D, Bloodgood B, Piercy K, George SM, Kraus WE; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Effects of Physical Activity in Knee and Hip Osteoarthritis: A Systematic Umbrella Review. Med Sci Sports Exerc. 2019 Jun;51(6):1324-1339. 24. Kumar D, Manal KT, Rudolph KS. Knee joint loading during gait in healthy controls and individuals with knee osteoarthritis. Osteoarthritis Cartilage. 2013 Feb;21(2):298-305. 25. 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. 26. 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. 27. Li CS, Karlsson J, Winemaker M, Sancheti P, Bhandari M. Orthopedic surgeons feel that there is a treatment gap in management of early OA: international survey. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):363-78 28. 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. 29. 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 30. 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. 31. 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. 32. 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. 33. NICE Guidelines - Osteoarthritis in over 16s: diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2022 Oct 19. 34. 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. 35. 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. 36. Ramsey DK, Russell ME. Unloader Braces for Medial Compartment Knee Osteoarthritis: Implications on Mediating Progression. Sports Health - A Multidisciplinary Approach. 2009;1(5):416-426. 37. Richards J, Jones R, Kim W. Biomechanical changes in the conservative treatment of medial compartment osteoarthritis of the knee using valgus bracing. ICRS 2006 38. The Comprehensive Textbook of Clinical Biomechanics, 2nd Edition. Elsevier 2018. ISBN 9780702054891. 39. Schnitzer TJ, Popovich JM, Anderson GBJ, Andriacchi TP. Effect of piroxicam on gait in patients with osteoarthritis of the knee. Arthritis and Rheumatism 1993;9:1207–13. 40. Segal NA, Glass NA. Is quadriceps muscle weakness a risk factor for incident or progressive knee osteoarthritis? Phys Sportsmed. 2011;39(4):44-50. 41. 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. 42. Shelburne KB, Torry MR, Pandy MG. Contributions of muscles, ligaments, and the ground-reaction force to tibiofemoral joint loading during normal gait. J Orthop Res. 2006 Oct;24(10):1983-90. 43. 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. 44. 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. 45. Tveit M, Rosengren BE, Nilsson JÅ, Karlsson MK. Former male elite athletes have a higher prevalence of osteoarthritis and arthroplasty in the hip and knee than expected. Am J Sports Med. 2012 Mar;40(3):527-33. 46. Waller C, Hayes D, Block JE, London NJ. Unload it: the key to the treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1823-9. 47. 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. 48. WHO July 2023 Osteoarthritis Key Facts https://www.who.int/news-room/fact-sheets/detail/osteoarthritis 49. 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.

INTRODUCING ROAM™ OA BY DONJOY®

ROAM™ OA is the newest innovation in offloader braces from DonJoy®. Indicated for patients with symptoms, physical findings or radiographic evidence of moderate to severe unicompartmental knee osteoarthritis, ROAM helps improve mobility and provides relief by offloading the pressure of unicompartmental osteoarthritis or other knee pain. Biomechanical testing* showed an improved biomechanical gait pattern in patients with moderate-to-severe knee OA (KL grade 3-4) wearing a ROAM OA brace.

* Multicenter biomechanical study including 14 patients (St. Luke's University Health Network, Pennsylvania and Rush University, Chicago, USA).

ROAM ™ OA REDUCED KNEE ADDUCTION ANGLES IN MAJORITY OF PATIENTS. Lower knee adduction angle led to a more balanced mediolateral load distribution.

The blue line shows joint movement and joint angle changes during gait 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 distribution.

JOINT ANGLES

KNEE FLEXION

KNEE ADDUCTION

20.6

69.1

16.6

51.8

12.6

34.4

8.5

17.1

Flexion

4.5

Extension

–0.3

Adduction

Abduction

0.0 25.0 50.0 75.0 100.0 % of gait cycle

DONJOY ROAM OA

No Brace

ROAM OA 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 movements during stance phase of gait. 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.

JOINT MOMENT (EXTERNAL)

KNEE FLEXION

KNEE ADDUCTION

.29

1.2

Flexion

0.11

0.8

Adduction

Extension

–0.07

–0.5

Abduction

–0.26

–0.2

–0.44

–0.1

0.0 25.0 50.0 75.0 100.0 % of gait cycle

DONJOY ® OA BRACES

Depending on the osteoarthritis severity, and the activity level of the patient, DonJoy ® offers a wide choice of off-loading braces.

Please consult your healthcare professional prior to use.

CLIMA-FLEX OA®

DONJOY OA GO®

NEW

OA REACTION WEB®

MILD

EARLY

Fig. 12: Positioning of DonJoy OA braces

CUSTOM OA DEFIANCE®

OA ADJUSTER™ 3

OA NANO®

OA FULLFORCE ®

ROAM™ OA

SEVERE

NEW

MODERATE

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NSW 2086 AUSTRALIA T : 1300 66 77 30 E : customerservice.au@enovis.com China A312 SOHO ZhongShan Plaza 1055 W, West ZhongShan Rd Shanghai, 200051 CHINA T : (8621) 6031 9989 E : shujun.tang@enovis.com

Italy Centro Direzionale Milanofiori

Strada 1, Palazzo F9 20090 Assago (MI) ITALY T : +39 02 835 98001 E : vendite@enovis.com

Spain Ctra. D`Esplugues, 225 2 ª B 08940 Cornellà de Llobregat Barcelona SPAIN

T : +34 93 480 32 02 E : ventas@enovis.com

USA 2900 Lake Vista Drive

Lewisville TX 75067 U.S.A. T : 760 727 1280 E : customercare@enovis.com

1a Guildford Business Park, Guildford, Surrey, GU2 8XG, UNITED KINGDOM enovis-medtech.eu

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