PROTECTED USE Foot & Ankle Fractures

• Partial/Complete break in any bones of the foot or bones around ankle i.e. medial & lateral malleoli

• Prevalence

– ~2/1000 per year, 14,000 cases in HK

per year 2

– ~9% of all injuries occur in workplace 1

• Recovery – Usually takes 6-8 weeks for bones to

heal, some even take up to 2 years AAOS 2007 Grimm JD & Fallet L 1999

PROTECTED USE Foot & Ankle Fractures

• Causes

– Direct trauma e.g. twisting, direct blow

– Overuse i.e. stress fracture

• Signs & Symptoms

– Pain

– Swelling & Bruising

– Unable to bear weight

– Sometimes with deformity

• Management --- depends on type & severity

– Conservative Treatment: Closed reduction to restore alignment followed by immobilization, mainly for stable fracture

– Surgical Treatment: Reduction & internal/external fixation with screws, plates or wires, mainly for unstable/non-union fracture

AAOS 2007 2

PROTECTED USE

Traditional Treatment Approach for Fractures

RICE - Swelling

- Pain

Conservative Treatment Immobilized in

cast for 6-8 weeks

Surgical Treatment

Fracture occur

Traditionally, no other alternatives to keep patient mobile while protecting fracture site at the same time

However, prolonged immobilization: results in undesirable outcomes affects strength of the healing bone

PROTECTED USE

PROTECTED USE Undesirable Outcomes of Casting

• Muscle atrophy 11

– Calf muscle size & force are reduced by 20%-32% & 40-53% respectively in patients with ankle fractures after 6-8 weeks of cast immobilization

– Muscle performance can only be reversed with 10 weeks of supervised physical therapy

• Joint Stiffness 18

– Muscles & tendons become short and inextensible after immobilization

– Stiffness and torque of passive ankle movement take >3 months to recover

• Possible Complications of Casting e.g. Compartment syndrome, dermatitis

Shaffer MA et al 2000 Nightingale EJ et al 2007

PROTECTED USE Complications of Cast or Splint Immobilization

• Compartment syndrome

• Ischemia

• Heat injury

• Pressure sores and skin breakdown

• Infection

• Dermatitis

• Neurologic injury

note: Listed in order from most clinically relevant to least clinically relevant.

Ischemia

Compartment syndrome

Pressure sores and infection

Dermatitis

PROTECTED USE

• Bone will adapt to the loads it is placed under. If loading on a particular bone increases, the bone will remodel itself over time to become stronger to resist that sort of loading.

• If the loading on a bone decreases, the bone will become weaker due to turnover

• Early mobilization - application of stress allows bones and ligaments to heal better and stronger

Wolff’s Law - Bone Healing

Key: PROTECTED USE

Without weight bearing Loss of bone density

PROTECTED USE

Wolff’s Law - Examples

Increases loading – stronger bone & soft tissue

Decreases loading – weaker bone (osteoporosis) & soft tissue (atrophy)

Aircast Pneumatic Walking Brace---

• Allows mobilization while providing protection to injured part by the semi-rigid shells & custom-inflated aircells

• Pulsating, graduated compression during walking to help reduce edema for faster healing.

• Adjustable & customizable --- adapt to sizes of limbs with individually inflated aircells.

• Removable for investigation & exercise

Allows early mobilization

Recommendation for lower leg fracture: Early motion to prevent stiffness, when starts to WB, most likely need to use crutches or a walker 16 AAOS 2010

16 Dale PA et al 1993 8 Kalish SR et al 1987 9 Stover & York 1979

PROTECTED USE

ONLY Aircast Walkers have all the clinical studies prove its claimed efficacy

PROTECTED USE

Aircast Walkers Proven Clinical Outcome

“a pressurized brace yields a stronger healed fracture than cast…”

“Pneumatic Walker resulted in “a significantly diminished incidence of lower extremity atrophy and osteoporosis”

For reduction of gastrocnemius muscle activity, the Aircast® FP Walker was more effective than cast.

Functional Outcome of Surgery for Fractures of the Ankle

“time from surgery to return to work was 50% lower in the Walker group than in the casted group: 53 days vs. 106 days. (Koval et al, JBJS 2000)

“patients in Walker recovered 3 weeks earlier and returned to work 8 days earlier than those in cast…”

PROTECTED USE Achilles Tendon Tendinopathy /Rupture Achilles Tendon Rupture, Current Concepts in Orthopaedics, 2008 Achilles Tendinopathy, Current Concepts in Orthopaedics, 2010

Conservative treatment (Non Operative) - Pneumatic Walker is preferred over cast (4-12 weeks) • Functional management of Achilles tendon rupture: A viable option for non-operative management. S.

Karkhanis et al, Foot and Ankle Surgery Int 2009. • Of the 107 Achilles tendons, 105 (98%) healed with an average discharge time of 22 weeks. complication

rate is 11%, compare with 24% by surgical treatment.

Surgical Management - Post-op: Pneumatic walker is preferred over cast for 4-8 weeks. • Operative versus Nonoperative Treatment of Acute Achilles Tendon Ruptures. A Multicenter Randomized

Trial Using Accelerated Functional Rehabilitation K Willits et al JBJS, Vol 92-A, No.17, Dec 2010 • Similar clinical outcomes & less complications with non-operative functional treatment vs

operative treatment of Achilles Tendon Rupture

ESSKA

PROTECTED USE AirSelect Walker vs Pneumatic Walker

PROTECTED USE

Gait (Walking) Cycle The gait cycle extends from heel strike to heel strike of one leg and includes the stance and swing phases of both legs.

Functional Management of Walker

62% 38 %

PROTECTED USE

PROTECTED USE

PROTECTED USE Competition － Stick-Foam Walkers

Poor support – No circumferential, Semi-Rigid

Shell

Less protection of the limb for external force

No functional management – No benefit from

clinically proven Duplex Aircells technology

No support by Aircells, extremity has a tendency to

shift in the boot, resulting in shear stress on the

lower limb and affects healing

The competitors walkers no optimal rocker sole.

Rocker sole on Aircast walker provides superior

walking gait (R&D with gait analysis)

Bledsoe

Breg

Aircast Airselect vs Ossur Rebound

PROTECTED USE

Knee flexion/extension

Ossur: increased knee flexion during swing phase

To ensure foot clearance

More energy expenditure

Aberrant from normal gait pattern

Earlier fatigue

PROTECTED USE Aircast Vs Ossur Centre of Pressure medial-lateral

• Ground reaction force more lateral in Ossur • Foot position more external rotation in Ossur • may cause strain on the MCL and discomfort to the knee

• considerably more laterally located centre of pressure in the Ossur Rebound

PROTECTED USE

Knee moments

Extension moment when the body moves over the stance limb (before toe-off) is considerably high with the Ossur Walker and could cause hyperextension

In healthy knee hyperext is prevented by hamstrings.

In pathologic or fatigue knee balanced muscle activity may be compromised and hence the hyperextension may persist and cause pain.

PROTECTED USE Aircast Airselect vs VACO cast

PROTECTED USE

Reduction in both Direct & Indirect Health-care Costs

$ Shorter hospital stay 3Simanski CJP 2006

– “the patients in the cast immobilization group stayed 3 days longer in the hospital than the early WB group”

Cost-Effectiveness

$ Currently the lowest charge per bed (Private hospital): $___/day

$ This treatment strategy saves $___

PROTECTED USE Cost Utility

• Re-cast $ Cast will become loosened as the swelling goes down or

when atrophy occurs. Loosened cast has lost its functions and

becomes an extra burden to the limb. Thus it needs to be changed frequently

$ Initial cost: US$25.52 22Cooke MW et al 2009

$ Re-cast: US$22.2 @ 23Sprague S et al 2002

$ Removal of cast: US$9.4 @ $ Each re-casting costs: US$ 31.6

$ Clinical re-visit after re-cast to make sure no complications occur

Time-consuming More days of

absence from work

24 Verity 2007 2 AAOS 2007

PROTECTED USE

$ Earlier return to work & sports 7 Egol KA 2000, 3 Simanski CJP 2006. 15 Whitelaw JG 1991

“ the mean time from surgery to return to work was 53.3 days for early mobilization with functional brace group and 106.5 days for cast immobilization group”

Return to work 53 Days earlier

Minimum Cost of absence from work: ~US$30/Day (Minimum Wage in HK) Early motion with pneumatic walking brace saves society:

~US$1500

Reduced Lose in Labor Productivity

PROTECTED USE

Functional Manageme Better quality of life • Better Quality of Life:

– More mobile

– Able to self-care

– Earlier return to daily activities & work

– Less pain/discomfort/complications

– Possibly les anxiety/depression

ED-5D Questionnaire A standardised, generic measure of health status for clinical and economic appraisal

Functional bracing allows early

mobilization, thus ensures patients to have good QoL in at

least 4 out of 5 dimensions

PROTECTED USE

Early mobilization is the key with walking brace

• Better Clinical Outcomes – Better ankle functions

– Improved bone healing

• Lower Risk of Complications

• More Cost-Effective – Shorter hospital stay

• Reduced Lose in Labor Productivity – Earlier return to work

• Better Quality of Life – Earlier return to daily activities & sports

PROTECTED USE

1. Injuries of the Foot and Ankle in Occupational Medicine: A 1-Year Study Grimm DJ & Fallet L, The Journal of Foot & Ankle Surgery 38(2): 102-108, 1999 2. Ankle Fractures American Academy of Orthopaedic Surgeons(AAOS) 2007 3. Functional Treatment and Early Weightbearing After an Ankle Fracture: AProspective Study Simanski CJP et al., J Orthop Trauma 20(2): 108-114, 2006 4. Use of a Cast Compared with a Functional Ankle Brace After Operative Treatment of an Ankle Fracture: A Prospective, Randomized Study Lehtonen H et al., Bone Joint Surg. 85A(2):205-211, 2003 5. The Law of Bone Remodeling Wolff J., Berlin Heidelberg: New York: Springer, 1986 6. Tibia (Shinbone) Shaft Fractures American Academy of Orthopaedic Surgeons(AAOS) 2010 7. Functional outcome of surgery for fractures of the ankle: a prospective, randomised comparison of management in a cast or a functional brace Egol KA et al., J Bone Joint Surg. 82B(2):246-249, 2000 8. The Aircast Walking Brace versus Conventional Casting Methods: A Comparison Study Kalish SR et al., Journal of the American Podiatric Medical Association 77(11): 589-595, 1987 9. The Aircast/AirStirrup System for Graduated Management of Lower Extremity Injuries Stover CN & York JM, Scientific Exhibit Paper, AAOS, San Francisco, 1979 10. Comparison of Two Conservative Methods of Treating an Isolated Fracture of the Lateral Malleolus Port AM et al., J Bone Joint Surg 78B(4): 568-572, 1996 11. Effects of Immobilization on Plantar-Flexion Torque, Fatigue Resistance, and Functional Ability Shaffer MA et al., PHYS THER 80(8): 769-780, 2000

12. Following an Ankle Fracture Early Weight Bearing After Posterior Malleolar Fractures: An Experimental and Prospective Clinical Study Papachristou G et al., The Journal of Foot & Ankle Surgery 42(2): 99-104, 2003

References

PROTECTED USE 13. Mobilization after operation of ankle fractures: Good results of early motion and weight bearing

Ahl T et al., Acts Orthop Scand 59(3): 302-306,1988

14. The Effect of a Pneumatic Leg Brace on Return to Play in Athletes with Tibial Stress Fractures

Swenson EJ et al., Am J Sports Med 25(3): 322-328, 1997

15. A Pneumatic Leg Brace for the Treatment of Tibial Stress Fractures

Whitelaw GP et al., Clinical Orthopaedics and Related Research 270: 301-305, 1991

16. A new Concept in Fracture Immobilization: The Application of a Pressurized Brace

Dale PA et al., Clinical Orthopaedics and Related Research 295: 264-269, 1993

17. Effects of Intermittent Pneumatic Soft-Tissue Compression of Fracture-Healing in an Animal Model

Park SH & Silva M, J Bone Joint Surg 85A(8): 1446-1453, 2003

18. Passive Dorsiflexion Flexibility after Cast Immobilization for Ankle Fracture

Nightingale EJ et al., Clinical Orthopaedics and Related Research 456: 65-69, 2007

19. AAFP 2009 Splints and Casts: Indications and Methods

Boyd A et al., Am Fam Physician 80(5):491-499, 2009

20. Stress Fracture of the Foot and Ankle

American Academy of Orthopaedic Surgeons (AAOS) 2009

21. Update on Acute Ankle Sprains

Tiemstra J D, Am Fam Physician 85(12), 2012

22. Treatment of severe ankle sprain: a pragmatic randomized controlled trial comparing the clinical effectiveness and cost-effectiveness of the three types of mechanical ankle support with tubular bandage. The CAST trial

Cooke MW et al., Health Technology Assessment 13(13): 1-121, 2009

23. An economic evaluation of early versus delayed operative treatment in patients with closed tibial shaft fractures

Sprague S et al., Arch Orthop Trauma Surg 122 :315–323, 2002

24. Treatment of Charcot foot and ankle with a prefabricated removable walker brace and custom insole.

Verity S et al., Foot and Ankle Surgery 268:1-6, 2007

References