The Future of Knee Bracing

Standards of Care

The REHABILITATOR™ System of Knee Bracing

Statistics

• 10% of the population over 60 has knee OA that impairs function

• TKR procedures are projected to grow 673% from now to 2030 to 3.8 million surgeries a year

• Increases from aging population and higher incidence of knee OA in both older and younger patients

Trends in Reimbursement for TKR

Requirement by insurers including Medicare that the physician document conservative management of Knee OA prior to approval for TKR

Standard of Care for the conservative management of knee OA prior to TKR should include use of OA REHABILITATOR™ therapy (the most clinically significant therapy to delay the progression of knee OA available)

Knee OA Standards of Care

• Use of NSAIDs

• Injections

• Exercise

• Unloading Knee Braces

Standard of Care

• “there is a need to develop alternative, efficacious, nonpharmacological, and nonsurgical treatment approaches that are capable of ameliorating the symptoms of knee OA.”

– Journal of Biomechanical Engineering, Pneumatic Osteoarthritis Knee Brace, April 2009

Unloader LimitationsEffective for pain relief during

use only

May reduce leg strength over time

No carry over benefit unbraced

w/no rehabilitation benefits, can not provide a stand alone “Standard of Care” alternative

What is a REHABILITATOR™?• A REHABILITATOR™ is an innovative patented knee brace

that dynamically corrects gait to realize significant rehabilitative benefits after several weeks of use.

• Uses pneumatic air to unload, protect and support the knee joint.

• Uses an extension swing assist to correct gait during use.• Has clinically proven “carry over”; patients demonstrate

UNBRACED significant gait improvements, reduction in pain, and gains in leg strength after 90 days of use.

Unloading Pneumatic Lever• The three-point leverage is achieved using a novel

pneumatic leverage system that, when pressurized evokes a valgus correction (for varus OA), which reduces excessive medial compartment loading.

• “pneumatic soft materials can counterbalance the negative influence of the adduction moment and thus alleviate its negative influence on the progression of OA. The brace is capable of unloading 90 – 100% of the excessive adduction moment.”

– Journal of Biomechanical Engineering, Pneumatic Osteoarthritis Knee Brace, April 2009

New Clinical Research

Recent clinical research has identified a consistent abnormal gait that deteriorates as OA worsens

“Abnormal OA Gait” is strongly linked to OA progressionAbnormal OA Gait reduces pain, but significantly

increases the wear and tear on the impacted joint compartment (joint biomechanics change)

The affected knee loses quadriceps strength over time because of diminished use with altered gait biomechanics, decreasing dynamic support of the affected knee compartment

Quadriceps strength 98 OA patients to Swedish and Fearon data on 79 Normal patients

Male OA Male normal Female OA Female normal

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(Force/BW)*100

Diminished Quad Strength Impact• Significant reduction of quad strength reduces the

knee compartment dynamic support (joint space balance)

• Increased knee adduction moment w/ gait• Altered ankle / foot biomechanics (lateral loading of

ankle w/ varus OA) further reducing quad strength over time

• Increased torque in the knee joint w/ ambulation over time

• Diminished functional capabilities over time

New Standard of Care for the Conservative Management of Knee OA

• Gait rehabilitating dynamic knee bracing that in 90 days will increase quad strength by 46%, hamstring strength by 29%

• Improves gait biomechanics UNBRACED w/ improved knee extension, walking speed, total ROM in gait, foot placement, and reduced abnormal knee movements.

• Significantly reduces knee pain UNBRACED • Reduces knee adduction moment 48% compared to

14% from 90 days of exercise

Prospective randomized study to assess effect of OA REHABILITATOR™

in Kellegren Lawrence 3, 4 patientsN= 57OA REHABILITATOR™ = 27Control = 30Dropped out study , Brace = 5, Control = 7

Patients wore brace for 3 hours or more

Gait and Strength, scores and functional tests at initial visit and at 90 days UNBRACED.

Improvement in 90 days of Brace use Gait parameter

Walking speed 12%

Knee extension 6 degrees (-1-22)

Total ROM in Gait 12 degrees (7-33)

Foot placement 1.7 cms (-0.9 to 6 cms)

Loading response Knee flexion 9 degrees (-4 to 11)

Reduced abnormal knee moments 11/22

All Gait studies performed without brace to test retained effect of the brace

Gait improvement after 90 days of OA REHABILITATOR™

Reduction in Adduction Moment

Pre Brace

After 3 months of brace use

Bhave 2013

Biodex Isokinetic Dynamometer

• Testing at 60 degrees• Lever arm same

length• 5 REPS each side• Average Peak torque

in FT/LB• For comparison (Force/BW)*100

Strength comparison OA REHABILITATOR™vs. control

Condition Percentage change

OA REHABILITATOR™ Quadriceps strength

+46% (10.5% - 136%)

OA REHABILITATOR™ Hamstring strength

+29% (-2% -80%)

Control Quadriceps strength -10.1% (-50% - 48%)

Control Hamstrings strength -0.5% (-43% - 48%)

All strength studies performed without brace to test retained effect of the brace

Strengthening Brace

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OA REHABILITATOR vs. control

Visit 1 90 days

Improvement in quadriceps strength in braced group

vs. loss of strength in control group at 90 days

Bracecontrol

Force/BW*100

Improvement in hamstring strength in braced group vs.

loss of strength in control group at 90 days

Visit 1 90 days

Bracecontrol

Force/BW*100

% change in quadriceps strength in braced patients vs. control

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Cell Bar ChartError Bars: ± 1 Standard Error(s)

OA REHABILITATOR™

Control

Force/BW*100

% quad Strength change

Result

OA REHABILITATOR™

+ 46%

Control -10.1%

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Cell Bar ChartError Bars: ± 1 Standard Deviation(s)

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Cell Bar ChartError Bars: ± 1 Standard Deviation(s)

Pre Brace Post Brace

Post Brace

Pre Brace

Improvement in quadriceps and hamstring strength with 90 days of OA REHABILITATOR™ use

Quadriceps

Hamstrings

Force/BW*100

P=0.001

P=0.011

% change in hamstring strength in braced patients vs. control

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OA REHABILITATOR™ Control

Force/BW*100

% hams Strength change

Result

OA REHABILITATOR™

+ 29%

Control -0.5%

Improvement in thigh strength in braced group vs.

loss of strength in control group at 90 days

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Cell Bar ChartError Bars: ± 1 Standard Error(s)

Force/BW*100

OA REHABILITATOR™

Control

Quadriceps Hamstrings

HamstringsQuadriceps

Weaker muscles showed greater gain in strength

Conversion to TKA

• Brace = 2• Control = 5

Social factors also influenced these decisions

Bhave 2013

Pre Brace

• LEFS =34• Pain score 5/10• Single limb stance time = 9• Celebrex = BID• Injection every 3 moths• Walking limited to 2 city blocks at a time

Bhave 2013

Bhave 2013

Post Brace (1 year out)

• LEFS =54• Pain score 2/10• Single limb stance time = 19• Celebrex STOPPED• Injection only 1 in last one year• Walking up to I.5 miles

Bhave 2013

Wearing schedule 3 to 4 hours per day

Conclusion – Knee OA Rehabilitation

Gait retraining effects retained without the braceQuad and hams strengtheningImproved foot position w/ gaitReduced rate of TKA in brace groupReduced VAS pain scoresReduced TUG time Significantly delays the progression of knee OA

Bhave 2013

Potential useOsteoarthritis Knee varus or valgusPrehabilitationRehabilitationReduced rate of TKA

Potential prehabiltation market to grow 673% by 2030

Potential worldwide market potential of 60 Million units *(rehabilitation)

Bhave 2013

PrehabilitationRehabilitating the affected leg prior to a TKR to significantly

improve patient outcomes.

Use the OA REHABILITATOR™ 6 – 12 weeks prior to TKR surgery

Strengthen hamstring and quads and normalize gait biomechanics prior to surgery

Accelerates recovery and reduces risks of chronic post TKR issues

Prehabilitation

• Estimated number of TKA’s currently is over 600,000 per year

• Growth in TKA’s projected at 673% by 2030

• Projected TKA’s to 3.48 million procedures by 2030

• Currently approximately 10% of Medicare expenditure is for TKA’s

OA REHABILITATOR™ Summary

• Why simply unload the OA knee when you can rehabilitate and delay the progression of knee OA

• Significant opportunity to redefine the Knee OA Standard of Care to include a rehabilitative bracing option.

• New treatment for the prehabilitation prior to TKA to significantly improve patient outcomes and minimize TKA chronic post operative issues

• Significant growth in TKA’s from now to 2030 provide a bracing prehabilitation opportunity