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Problem statement

There is a need to approach knee braces at the user interaction stage and develop a brace that efficiently suits the user through the recovery process and reentry to their previous lifestyle.


Who cares? There are approximately 19.3 million knee injuries in the US each year. Knee injuries are the most common reason for visiting an orthopaedic surgeon.

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Over the last 15 years knee injuries have increased in frequency by 172%

Athletes in contact sports such as soccer and football are 10x more likely to sustain serious injuries than their counterparts in non-contact sports.

A serious knee injury can mean surgery, months of rehabilitation and physical therapy and, according to medical statistics, an increased likelihood of re-injury and future osteoarthritis.

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What’s in a knee?

femur quadriceps tendon

patella

posterior collateral ligament

posterior cruciate ligament

articular cartilage meniscus

medial collateral ligament

patellar tendon

tibia

anterior cruciate ligament


When do knee injuries ocuur?

po

p!

planting/cutting/pivoting/ sudden deceleration

>10% hyperextension

over 1/2 of people who tear cruciate ligaments say that there was an audible pop at the time of the injury

a blow to any side of the knee

75% of cruciate ligament injuries happen in noncontact situations

landing with straight legs from a jump such as rebounding in basketball or heading the ball in soccer can cause hyperextension. 10% of hyperextension is the start of the danger zone.

sports like soccer, basketball and football require frequent, sharp movements to change direction.

many contact sports run the athlete the risk of knee injury via unexpected blows to the knee. a football tackle to any side of the knee can over extert the knee ligaments, causing them to tear.


Why does knee brace design need to be addressed?


Existing Post-op Knee Braces ProCare KneeRANGER II Universal

ProCare KneeRANGER Universal

ProCare KneeRANGER Lite

ProCare KneeRANGER

Post-operative immobilization with protected range-of-motion.

A post-operative immobilization brace

Polycentric hinge allows for convenient dial-in adjustment with flexion and extension stops at 0°, 15°, 30°, 60° and 90°.

It has a protected range-ofmotion with 7.5 incremental settings between 0°and 120° of flexion and 0°and 70°of extension.

Economical, lightweight, universal leg brace for warmer climates.

A one-piece easy on/off design and breathable nylon/fiber/ flannelette construction.

Narrow band circumferential cuffs replace full cut leg wraps.

The protected range-of-motion has settings between 0° - 120° of flexion and 0° - 70° of extension in 7-1/2 increments.

Trimmable foam leg wraps for customized fit. Medial/lateral plastic shells riveted to hinge bars provide additional support. Accommodates ankle/shoe insert for added rotational control. Ideal for providing protected range-of-motion for postoperative immobilization.

Medial/lateral plastic shells provide additional rigid support and immobilization

Provides immobilization and protected range-of-motion in 7.5° increments from 0° - 120° of flexion and 0° - 70° of extension. Ideal for immobilization and protected range-of-motion associated with ACL, PCL, LCL and MCL surgeries/repair.

This brace accommodates ankle/ shoe Insert for added rotational control.


Existing Post-op Knee Braces ProCare KneeRANGER II

ProCare KneeRANGER Rehab Splint

ProCare 3 Panel Knee Splint

ProCare Universal Foam Knee Splint

One-piece, 24” length design allows for easy application and adjustment.

Full foam wrap may be trimmed for customized fit.

3-piece nylon/fiber laminate construction provides postoperative knee support and immobilization.

Constructed of open cell foam and detachable medial/lateral aluminum I-beam stay panels for easy adjustment and custom fit.

Adjustable side panels with I-beam stays and patella strap allow for correct fit and easy application.

Three double bend posterior aluminum stays.

Dual axis hinge provides protected, full range-of-motion control with flexion and extension stops at 0°, 15°, 30°, 60°, and 90°. Breathable nylon/fiber/ flannelette construction. Integrated strap/hinge bar design accommodates Ankle/ Shoe Insert for added rotational control. Ideal for immobilization and protected range-of-motion associated with ACL, PCL, LCL and MCL surgeries/repairs

Anterior plastic shells provide additional compression and support. Protected range-of-motion in 7.5° increments with settings between 0° - 120° of flexion and 0° - 70° extension. Ideal for immobilization and protected range-of-motion of the knee Fits right or left

Three posterior aluminum stays for proper immobilization. Adjustable foam pop pad Ideal for post-operative immobilization of the knee joint; collateral ligament sprains; patellar subluxations. Loop lock closure

Alternating web straps provide dual adjustability, using a D-ring buckle and a hook tab. After fitting, knee immobilizer can easily be removed by simply releasing hook tab. Ideal for post-operative immobilization, grade 1 and grade 2 collateral ligament sprain, and patella subluxations


Existing Knee Brace Accessories DonJoy Knee Brace Undersleeve

DonJoy Neoprene Knee Brace Undersleeve

DonJoy Sports Brace Cover

DonJoy Impact Guard Knee And Shin Protector

Increases comfort and minimizes chaffing.

Increases Comfort.

Polyester material ensures a snug fit over the brace.

Designed to protect the shin and knee from blunt blows.

Padding protects the frame and hinge during activities.

Features a hinge cover, which prevents ripping of pants and/or uniforms.

Protects skin, reduces abrasion and prevents rashes. Manages moisture. Tapered design reduces migration. Washable. No rubber or latex or elastic bands. Fits Left or Right Leg.

Protects Skin, Reduces Abrasion and Prevent Rashes. Perforated neoprene allows skin to breath and reduces moisture.

Elastic on top and bottom of cover makes it easy to put on.

Tapered design reduces migration.

Can be worn during team sports to protect others.

Washable.

Keeps hinges clean from dirt.

Fits Left or Right Leg.

Fits right or left leg. Machine washable makes this knee brace cover easy to clean.


Existing Knee Braces DonJoy Drytex Playmaker Wraparound/ Sleeve

DonJoy Economy Hinged Knee

DonJoy Protective Knee Guard

ProCare KneeRANGER Neoprene

Polycentric hinges conform to the knee joint’s natural motion so you’ll get uninhibited movement of your knee.

Polycentric hinge with 10-3/4” aluminum uprights

High strength stainless steel hinge bar

Uprights can be removed for washing

Single upright

Designed for wear when compressive support, motion control, and heat retention are indicated

Drytex fabric is a neoprene alternative that provides better airflow, which is ideal for those who live in warmer climates or suffer from allergies. You can choose the style you’re most comfortable putting on.

Designed to be worn during active periods or while playing sports.

Available in strap-on and tape-on styles

Contoured 3/16” neoprene sleeve Range of motion settings between 0 - 120 of flexion and 0 - 70 extension in 7-1/2 increments with a contoured 3/16” neoprene sleeve Available in 6 sizes


Existing Knee Therapy Devices Aircast Knee Cryo/Cuff

DonJoy Dura Soft Knee Sleeve and Knee Wrap

DonJoy Dura Kold Consumer Wrap

Aircast Knee Cryo/Cuff Autochill System

Anatomic cuff design for complete coverage of affected area

Removable DuraSoft inserts allow for continuous cryotherapy.

Long term cold therapy with DuraKold.

Air Pump - pressurizes the cooler, automatically recycling warm water for cold.

Measured compression for patient comfort

The malleable packs and elastic straps on the wraps provide optimal compression.

Controlled cold eliminates the risk of tissue damage Self-contained design eliminates the need for a cooler

The knee sleeve is designed to load the packs into anterior pockets for easy exchange of ice packs.

Even adjustable compression with contact closures. The DuraKold wraps are reusable to use extensively during rehab and future general use.

Air Tube Assembly exchanges air between pump and cooler. Wall Adapter - provides power for operation. Anatomic cuff design for complete coverage of affected area. Measured compression for patient comfort. Controlled cold eliminates the risk of tissue damage. Detachable cooler without treatment interruption


Recovery Timeline

Weeks 1-2 Focus: range of motion

Weeks 7-12

Action: frequent extension/ flexion exercises

Focus: mild sports activities Action: jogging, outdoor cycling, pool workouts

0

1

2

3

4

5

6

7

8

9

10

Weeks 3-6 Focus: strength /motion Action:

limited weight lifting and movement exercises, stationary bike

Months 4-7 The remainder of the rehabilitation and a full return to sports is dependent on the doctor and physical therapist and their opinion of the patient’s progress.

11

12


Interview Beth Miotke Crucial Information: “Knee braces shouldn’t be used as the main aspect of preventing another tear. The athlete should be able to perform without one and use one for minimal aid in stability. The main reason to use a knee brace when returning to a sport is the mental comfort it gives.” “I allowed one of my athletes to return with a knee brace (Mueller hinged knee brace) for the piece of mind it gave her. “

moisture control/ heat management materials Qualifications:

separate base sleeve with non-slip grips

PTA, ATC is a native of Lafayette and has been with Lafayette Rehabilitation Services since 2001. She received her undergraduate degree in Athletic Training from the University of Indianapolis in 2000. Beth then went on to earn a Physical Therapist Assistant Degree from the University of Indianapolis in 2001.

provides stability support and protection to knee “near-normal” knee motion

My interview with Beth was interesting because she is not an advocate of allowing athletes to use a brace when returning to their sport. Therefore, she gave a critical opinion of the practice and in turn the most minimal uses of a brace.


How did you feel about the ease/difficulty of using a towel? Would you choose that Surveys knee injury victims method again?

wore immediately after your ACL with or praises of the knee brace you What were your biggest frustrations reconstruction? straps = lots of bruises, pain, was to make the straps very tight. Tight The only way to keep my leg straight What were your biggest frustrations with or praises of the knee brace you wore immediately after your ACL and a shrinking leg. :( reconstruction? wore immediately after your ACL with or praises of the knee brace you I didn’t wear my brace too often but when I did, it felt limiting or constricting What were your biggest frustrations days after your surgery? on my leg extension/ flexion exercises in the few your perform you did How ction? reconstru 1 CPM machine time.. I Hated dealing with the velcro all the 2 pulling my leg with a towel you wore immediately after your ACL member What were your biggest frustrations with or praises of the knee brace mily 3 with the help of a friend/fa How did you perform your extension/ flexion exercises in the few days after your surgery? reconstruction? 4 I didn’t do them like I should have 1 CPM machine Tight straps = lots of bruises, pain, after your surgery? n/ flexion exercises in the few days The only way to keep my leg straight was to make the straps very tight. 5 other... 2 pulling my leg with a towel How did you perform your extensio :( leg. and a shrinking 1 CPM machine 3 with the help of a friend/family member 2 pulling my leg with a towel 4 I didn’t do them like I should have 3 with the help of a friend/family member after your surgery? 5 other... How did you perform your extension/ flexion exercises in the few days 4 I didn’t do them like I should have 1 CPM machine ? Would you choose that method again? machine CPM the of culty ease/diffi 5 other... How did you feel about the 2 pulling my leg with a towel foot slide on the floor. Not ideal. lifted and lowered my leg, letting my 3 with the help of a friend/family member CPM wasn’t covered by insurance. I 4 I didn’t do them like I should have How did you feel about the ease/difficulty of the CPM machine? Would 5 other... you choose that method again? I don’t quite remember, but I felt like it was fairly easy. I would lie on the you choose that method again? did you wear a brace? couch and have the machine help culty of the CPM machine? Would When you went back to your sport How did you feel about the ease/diffi move my leg. I would probably do this method again. yes would i yea alot... it wasn’t that bad of a method it helped

It was ok. There are lots of methods... a t shirt works fine as long as its big enough.

What were your biggest frustrations with or praises of the knee brace you wore immediately after surgery? your When you went back to your sport did you wear a brace? way to keep my leg straight was to make the straps very tight. Tight straps = The onlyyes pain, and a shrinking leg. :( bruises, of lots How did you perform your extension/ flexion exercises in the few days after your surgery? method again? about the ease/difficulty of the CPM machine? Would you choose that How did you machine 1feelCPM foot slide on the floor. Not ideal. CPM wasn’t covered by insurance. I lifted and lowered my leg, letting my did you wear a brace? When you went back to your sport towel a with leg my pulling 2 Did it hinder you? Why or why not? yes member friend/family of aabrace? help the 3 with you wear didbrace sport your back to same you wentthe When It was as before and it was just as uncomfortable as ever yes do them like I should have 4 I didn’t to play? Why or why not? Were you timid to return in your return 5 other... no, i performed about the same level...

In your opinion what are the most important (1) to least important (5) aspects of a knee brace worn immediately after knee surgery?

Results: 1- comfort When you went back to your sport did you wear a brace? yes 2- multi-functionality/versatility Why or why not? play? to return your in return to it Were you timid I’ve learned that . Why: cautious be will I but 3ease of putting on/taking off though, timid be will believe I I’m actually still in recovery. I don’t life like this. I don’t want to spend the rest of my is horrible to have a bum knee and 4-attention to inhygiene Were you timid to return your return to play? Why or why not? when first worn braces of knee much though I wouldn’t t (1) to least important (5) aspectsNot In your opinion what are the most importan 5- breathability run the same because of the weight and limited movement. returning to a sport after surgery? 1 breathability lity 6- mass ofwhat brace 2 multi-functionality/versati In your opinion are the most important (1) to least important (5) aspects of knee braces worn when first on/taking off brace

Were you timid to return in your return to play? Why or why not? 3 ease of putting returning to a sport after surgery? first will be cautious. Why: I’ve learned that it knee braces worn when I’m actually still in recovery. I don’t believe I will be timid though, but I t (1) to least important (5) aspects of 4 attention to hygiene 1 breathability life like this. In your opinion what are the most importan is horrible to have a bum knee and I don’t want to spend the rest of my 5 mass of brace 2 multi-functionality/versatility returning to a sport after surgery? ations? consider other 6 1 breathability 3 ease of putting on/taking off brace 2 multi-functionality/versatility aspects of knee braces worn 4 attention to hygiene when first In your opinion what are the most important (1) to least important (5) 3 ease of putting on/taking off brace 5 mass of brace returning to a sport after surgery? 4 attention to hygiene 6 other considerations? 1 breathability 5 mass of brace of knee braces worn immediately ty/versatility 2 multi-functionali What were your biggest frustrations with or praises of the knee brace you wore immediately after your ACL t (1) to least important (5) aspectsWhat were your biggest frustrations with 6 other considerations? In your opinion what are the most importan or praises of the knee brace you wore 3 ease of putting on/taking off brace immediately after your ACL reconstruction? reconstruction? surgery? ction reconstru ACL after to hygiene 4 attention tely after your ACL you wore immedia It was smelly, It was a pain to pull off and put on because it was made of thick spandex. it felt like it was pulling my doctors told me that knee braces 1 breathability ns with or praises of the knee brace What were your biggest frustrations with or praises would do nothing for a torn ACL... they of brace were your biggest frustratioctionalit What lity y/versati of the knee brace you wore immediatel would only affect my confidence my knee back apart a little bit when5 Imass would bend my leg. It was extremely hard to position in the correct in walkingsoare I didn’t In your opinion wearimportant what y after your one. the most ACL 2 multi-fun reconstruction? (1) to least considerations? important ction? other 6 (5) aspects reconstru of brace knee braces worn immediately off g angle so that I felt like my knee was bending in the right backward direction. putting on/takin 3 ease of tely after ACL reconstruction surgery? a lot. which helped It was gigantic, bulky, t (5) aspects of knee braces worn immedia It didn’t allow for lockage clunky,t (1) least importan andtoweighed to hygiene most attention importan 4 likely most more the than are necessary what 1 breathability opinion In your How did you perform your extension/ flexion exercises in the few days after your surgery? How did you brace of perform mass 5 your extensio surgery? n/ flexion exercises in the few days 2 multi-functionality/versatility after ACL reconstruction after your surgery? 1 CPM machine 6 other considerations? 1 of CPM machine 1 breathability 3 ease putting on/taking off brace your 2 pulling my leg with a towel surgery? the few days after 2 pulling ctionality/versatility my leg with a towel multi-fun 4 attention your extension/ flexion exercises in to hygiene (1) to least important (5) aspects of knee braces worn How did 2you immediately the most important perform your extension/ whatofare opinion In your 3 with the help a friend/family member brace exercises in the few days after your surgery?How did you perform on/taking offflexion 3 with putting of the ease help 3 of a friend/fa machine 5 mass of CPM brace 1 mily member surgery? 1 CPM reconstruction after4ACL machine I didn’t do them like I should have hygiene 4 I considerations? didn’t do them like I should have 4 attention to 6 other 2 pulling my leg with a towel 1 breathability 2 pulling my leg with a towel 5 other... mily member 5 other... ) Any other negative 5 mass of brace 3 with the help of a friend/fa 2 multi-functionality/versatility you’d like to mention? (positive or 3 with the help of a friend/family member braces ce with experien ations? havethat should like Iknee aspects of4 your 6 other consider them other do Any didn’t brace I off on/taking putting of ease 3 4 I didn’t do them like I should have ts at all? 5 other... 4 attention to hygiene 5 other... work from 7am to 4pm and commen times daily. The problem is I have to might 5 mass of brace I was told that I should use a CPM multiple to do this, that would be great!! This to the braceAny other aspects of if your experience were possible to attach something it If with knee braces that you’d like to mention? (positive or negative) Any allowed to bulky. considerations? it isn’t are other 6 CPMs their reach How did you feel about the ease/difficulty of using a towel? Would you choose that method again? How did youfoot other other might be nice too. Most people can’t comments at all? feel about the ease/difficulty of the CPM machine? Would you ? (positive or negative) Any sound odd, but integrating a shoe choose that method again? with this on their own. knee braces that you’d like to mention deal with to ce have It was ok. There are lots of methods... a t shirt works fine as long as its big enough. experien people I liked your of often it because how aspects never let me knee become stiff, but Any other bend. I’m unsure though that methoditagain? choose youI didn’t it was also veryyy difficult to sleep Would ? machine CPM really the go of back to my sport so I have no real experience in. at all? using the brace much. commentsHow did you feel about the ease/difficulty of the CPM you feel about the ease/difficulty How did machine? Would you choose using thatinstead methodofagain? boots I would defiently do it again. boot... such as using the clips on the rding and I lied onthe myconcept snowboatable stomachofon the It was pretty easy, helped a lot, and a massage other Anylook into either had a family member push the leg, or I would I would with knee braces that you’d like to mention? (positive or negative) of your aspects pull it Any other When you went back to your sport did you experience wear a brace? with a towel When you went back to your sport of the boot. did you wear a brace? velcro. Using the material of the linear at all? comments yes yes I have to work from 7am to 4pm and no I was told that I should use a CPM multiple times daily. The problem is sport did you wear a brace? your might to This When great!! back be you would went that went this, do you back to to brace your the When to sport something did you wear a brace? CPMs are bulky. If it were possible to attach yes reach their foot if it isn’t allowed to yes sound odd, but integrating a shoe might be nice too. Most people can’t own. bend. I’m unsure though how often people have to deal with this on their Did it hinder you? Why or why not? Were you timid to return in your return It was the same brace as before and it was just as uncomfortable as ever to play? Why or why not? Yes, I have torn both knees ACL and to play? Why or why not? Were you timid to return in your return to play? I will probably never play soccer again. Were you timid to return in your return Why or why not? When i did return, I knew i wasn’t at full potential and full strength so was very bulkey. it made me nervous and I didn’t want allow for side movement at all and didn’t it yes, to mess up all the hard work and I only wear/wore it when I felt it necessary. It was PT i had just done. more of an annoyance than anything. Which is In your opinion what are the most important (1) to least important (5) aspects of knee braces worn when first why I wore it less and less and barely ever feel the need to wear it. returning to a sport after surgery? In your opinion what are the most importan t (1) to least important (5) aspects of worn when first of knee knee braces worn when first 1 breathability returning to a braces sport after surgery? t (1) to least important (5) aspects In your opinion what are the most important (1) In your opinion what are the most importan 2 multi-functionality/versatility to least important (5) aspects of knee braces worn 1 breathability whentofirst surgery? after returning sport a to a sport after returning surgery? 3 ease of putting on/taking off brace 2 multi-functionality/versatility ility breathab 1 1 breathability 4 attention to hygiene 3 ease of putting on/taking off brace 2 multi-functionality/versatility 2 multi-functionality/versatility 5 mass of brace 4 attention to hygiene 3 ease of putting on/taking off brace 3 ease of putting on/taking off brace 6 other considerations? 5 mass of brace 4 attention to hygiene 4 attention to hygiene 6 other considerations? 5 mass of brace 5 mass of brace 6 other considerations? 6 other considerations?

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yes

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Did I mention Whenityou waswent smelly? back to your sport did you wear

a brace

Any other aspects of your experience with knee Any other aspects of your that you’d worn braces knee like to mention? (5) aspects ?ofbraces important the most important (1) to least comments (positive or negative) Any In your opinion other all? at all? what areyes comments at I didn’t really go back to my sport so I have no immediately after ACL reconstruction surgery? real experience using the brace much. 1 breathability 2 multi-functionality/versatility 3 ease of putting on/taking off brace

It was bulky and black. It would have been great if it was a cool grey color. Did I mention it was smelly?

experience with knee braces that you’d

Any other aspects of your experien ce with knee braces that you’d like to mention? (positive or negative) ? (positive or negative) Any other commen to mention like ts at all? Any other Overall, the idea brace would be simple and as unnoticeable as possible but also serves a strong function in healing your knee

Setting the stage...  

Beginning of research.

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