Role of Spinal Orthosis in Management of Adolescent Idiopathic Scoliosis (AIS): Brief Insight

Dr Bhaskar Borgohain. MS. DNB

Faculty I/C Orthopaedics

NEIGRIHMS Shillong

With contribution from Balaphrang Marbaniang, NEIGRIHMS

BACKGROUND

• Bracing is widely prescribed across the world for AIS

• Blanket bracing is unscientific in AIS• Current literature lacks consistency for

both inclusion criteria and the definitions of brace effectiveness

• The decision to brace for AIS is often difficult for both clinicians and families.

Adolescent Idiopathic Scoliosis (AIS

The SPECTRUM OF VIEWS & BELIEFS

• Brace Definitely Works• Brace or No brace: Doesn’t Really matter!• Surgery is the gold standard• Surgery is the best conservative

approach!

• Efficacy• Safety issues• Convenience: Patient acceptance & Satisfaction Possibly there is a scientific middle path

Surgical rates after observation and bracing for AIS : An Evidence-Based Review.

• One cannot recommend one approach over the other to prevent the need for surgery

• The use of bracing relative to observation is supported by "troublingly inconsistent or inconclusive studies of any level." 

 

The aim of this paper

• Sum up current practices• Brief Insight of AIS Literature • Evidence : Understand the emerging

bottom line recommendation on evidence base. 

• Nihilism of skeptics to cautious expectancy • Cautious optimism: Growing amount of

literature has tested and endorses conservative treatments for AIS with brace

Definitions 

• Infantile scoliosis is classically defined as scoliosis that is first diagnosed in a child between birth and 3 yrs old: boys > girls : left> Rt. Curves

• Juvenile scoliosis: classically defined as scoliosis that is first diagnosed between 4 &10 yrs of age: boys > girls : left> Rt. Curves

• Idiopathic : Curve between 10 & 18 yrs of age is termed adolescent scoliosis (AIS)

AGE IS IMPORTANT

• Infantile: 0-3 years old (0.5%)• Juvenile: 4-11 years old (10.5%)• Adolescent: 10-18 years old (89%)• Adult: >18 years old

AIS affects about 2–3% of adolescent females aged 10-16 yrs.

• 90% are Female • Body image issues

• Scoliosis is a deformity: Characteristic lateral curvature of spine > 10°

• Measured by the Cobb’s method on standing upright spine radiographs.

Cobb’s method

Upper End Vertebra

Lower End Vertebra

End plates

Apical vertebra

The overall goal of Rx: Prevent the curve from worsening over time.

• The vast majority: Require No Rx other than regular check-ups: Only curves are monitored.

• Generally, patients are followed every 6 months until growth is complete.

• In general, bracing is initiated when the curve measures 200-250 in skeletally immature

• > 50 Curve Progression over 6 months is considered risk for further progression

Risk assessment

• Research shows that once a curve reaches 20-25 degrees, there is a good chance that the curve will progress during growth

• Therefore, bracing treatment is continued until the end of growth. 

Viewed in three dimensions: Constellation of deformities

• The lateral deviation of the spine in the frontal plane

• The rotational and • The rib cage

deformity in the transverse plane and

• Restore the sagittal plane

• Lordosis • Scoliosis• Rotation• Rib cage defects

NASH & MOE

Any conservative management like bracing of scoliosis should ideally aim at

• correcting all components of the deformity simultaneously

• Theoretically possible

• Technically challenging

• Practically cumbersome

• Less predictable cf modern surgical corrections

The strategy for the treatment :AIS

• Depends essentially : the magnitude and pattern of the deformity and

• Its potential for progression.

• To prevent curve progression during high risk period of skeletal growth.

Treatment options in AIS : 3 ‘O’ s

• Observation• Orthosis &• Operation

PT is an adjunct Corrective

surgery is the final common pathway in cases of failures

Orthosis

        

Observation

Operation

The 3 O’s of Rx options

       

  

ORTHOSIS

Principle: Three point fixation

To prevent curve progression during high risk period of skeletal growth.

MILWAUKEE BRACE

THE CONTROVERSIES

• Brace is the most common method to treat AIS : 250-400

• In common practice worldwide >30 years

• Several studies questioned the very role of brace for controlling curve

• Evidence level is fair to poor

SURGERY VS ORTHOSISRestlessness with tubular vision syndrome !

Breathless expectancy

Inborn Nihilism in Conservatism

 Balance

Brace related stress & lifestyle issue

• Braces in Adolescent Idiopathic Scoliosis (AIS) treatment seem to produce stress

• Controversy whether health related quality of life issues of brace treated adolescents are affected negatively

• Body image perception issue of mentally & socially growing adolescent leading to alterations in lifestyle.

VARIABLES

Scoliotic curve is a half known potential enemy

“Change is the only constant”

• Natural history of scoliosis ?• Depending on Age/sex/growth pattern,

curve type etc• Evidence alone is not enough• Level of evidence ?

The goal of surgical treatment

Two-fold: • First: to prevent curve progression &• Secondly : to obtain some curve

correction• Risks: Yes• Patient satisfaction: abstract

• Posterior approach is utilized most often and can be utilized for all curve types

SURGEON VS ORTHOTISRestlessness with Over-enthusiastic Tubular vision syndrome ! Proponent of Brace

Breathless expectancy on Braces

Inborn Nihilism in Conservatism ?

 Balance

EVIDENCE BASED MEDICINE

UNREALISTIC UNREALISTIC

PRAGMATISM

EXTENT AND SEVERITY ASSESSMENT: King classification of idiopathic scoliosis 

Defines 5 types of idiopathic scoliosis: the severity is based on · Cobb’S angle based on x-ray image · Determined flexibility index based on bending radiographs

PRIMARY AND COMPENSATORY SECONDARY CURVE

BALANCED CURVES

TYPES OF CURVES PrognosticationsRisk stratificationObjectivityImplications: Best RxOrthosis type & extent

During the past decade

• Several studies have demonstrated the True natural history of AIS

• Appears: AIS is positively affected by non-operative treatment, especially bracing.

• Physiotherapy, traction• Muscle stimulations etc• Various combinations• Unclear role

Indications for brace treatment

• Age: skeletal maturity• A growing child

presenting with a curve of 25°- 40° or

• A curve <25° but with documented progression.

•  A curve >200 may also indicate bracing, if 50 progression has been documented: 6 months

• Girls vs. Boys

Natural history : Risk of progression 

Data generated by the Scoliosis Research Society, Chicago, Illinois, USA

High Risk group identification Objective: To determine what radiographic or clinical

observations may be predictive of outcome. • Patients with a double curve with thoracic curve >35

degrees and the LPR angle is >12 degrees are significantly more likely to demonstrate curve progression. ( LPR angle : Lumbar-Pelvic Relationship Angle)

• In-brace correction for double curves of at least 25% and a patient's ability to wear the orthosis >18 hours/day significantly increased the likelihood of success.

- Katz DE, Durrani AA. Spine. 2001 Nov 1; 26(21):2354-61

Contraindications for bracing do exist !

• Child who has completed growth

• Growing child with a curve > 45°

• Growing child with < 25° without documented progression.

RISSER’S SIGN

Poor compliance to brace wearing is an important issue

• Linked to failure of braces.• Brace Duration: 24 Hours !!• Interestingly the results of

12 hours per day of bracing were similar to the results of 23 hours per day of bracing.

• Pressure Points/Discomfort• Boys• Milwaukee Brace

The Boston TLSO

• Fits under the arms and around the rib cage, lower back, and hips.

• Four Point Fixation• Minimum

limitations of activities

• 18-23 hours Wearing

• Maximum Available studies

Milwaukee Brace: Overkill-Obsolete

• Consisting of a Leather Girdle &

• Neck Ring • Connected By Metal

Struts: Superstructure     Prolonged use may induce

or complicate malocclusion unless the teeth and jaws are supported with retaining appliances.

Wilmington & Rosenberger brace

The Boston brace led to a series of under-arm braces that lacked the metal superstructure of the Milwaukee, including

Lyon, Rosenberger, Wilmington & Miami braces.

     Wilmington    Rosenberger

Lyon brace 

• Modified braces• Similar principles• Better tolerated

than Milwaukee

Brace-weaning

• Begins when the patient reaches skeletal maturity

• Determined as the finding of a Risser sign of 4

• Risser 4: > 12 months post-menarche and lack of growth in height.

The main purpose of scoliosis surgery

• Is to fuse the affected bones of curve.

• The fusion keeps the spine straight.

Favouring a brace: Evidence ?

• Bracing to slow down curve progression in patients with AIS has been the standard of care in the United States > 30 years,

• But the treatment’s effectiveness remains unclear !

ADVANTAGES & CHALLENGES of Brace

•  A scoliosis brace does not have decided mechanical advantages unlike a dental brace

• But in suitable candidates who are compliant with optimal brace wearing in a bracing program: the success rate is in the order of 80 percent in various reported case series

• So in these patients an operation is potentially avoided.

Widespread General agreementscurrently are

• There is no universally accepted standard approach to bracing for AIS.

• Not all cases of AIS need bracing

• Before bracing: x-ray documented progression of > 5 0 is recommended

• Skeletally immature patient: Bracing may be purposefully undertaken with curves 300-400

   The reason for this Selective bracing is that 1/3 of AIS curves > 30 degrees do not progress despite no Rx

Literature evidence !

Online survey : July-Nov 2008 to 30 Pediatric spine surgeons of the Canadian Pediatric Spinal Deformities Study Group. The response rate was 70% representing 12 Canadian spine centres.

Douglas L Hill, Eric C Parent , Edmond Lou et al: 7th International Conference on Conservative Management of Spinal Deformities. Montreal, Canada. May 2010

Surgeons had >80% agreement on bracing

• “Only in cases of progressive pre-menarchal females with 25-35 degree curves or

• 250 - 300 curves within 1 year of menarche had >80% agreement on bracing.

• Detection of curve progression increased the likelihood of recommending bracing by surgeons for curves < 35 Degrees”

Douglas L Hill, Eric C Parent , Edmond Lou et al

Bottom line of this study

“In spite of SRS guidelines and general agreement that braces are effective, there is little agreement among surgeons on Protocol or Methodology of treatment with a brace in AIS.

The likelihood that a girl with AIS will be prescribed a brace primarily depends on surgeon, brace prescription patterns, rather than spine curvature.”

Douglas L Hill, Eric C Parent , Edmond Lou et al

Patient satisfaction

• Patient satisfaction is an abstract & multidimensional concept

• Recognized & important component of evidence-based health care.

• Although there have been limited attempts to develop/use standardized, patient-

reported outcome (PRO) measures 

MILD CURVE: MORE COUNSELING 

  More attention will need to be given to those with mild but progressive curves to help improve patients’ understanding of their treatment and hence their compliance and satisfaction

Kenneth M. C. Cheung, Elaine Y. L. Cheng et al. INTERNATIONAL ORTHOPAEDICS 31(4): 507-511  

Blanket surgery: Role?2007

• Nonrandomized prospective comparative cohort of Operative versus  Observational management of AIS

• Scoliosis surgery results in a small increase in spine-related quality of life at 2 years compared to brace gr.

• This increase is of questionable clinical significance. • Decisions to operate on adolescents with scoliosis

should acknowledge only modest expectations about short-term gains in quality of life.

Howard Andrew , Donaldson Sandra Hedden Douglas  et al Spine:2007 32 (24):2715-2718

Observation Versus Bracing2007: Spine

• 16-year follow-up of original SRS brace study /Sweden

• Original study: Brace treatment was superior to electrical muscle stimulation, as well as observation alone, in the original study

• 2007: The curves of AIS with a moderate or smaller size at maturity did not deteriorate beyond their original curve

Danielsson AJ, Hasserius R, Ohlin A, Nachemson AL. Spine . 2007 15;32(20):2198-207.

Curve progression was related to immaturity

• No patients treated primarily with a brace had surgery, whereas 6 patients (10%) in the observation group required surgery during adolescence compared with none after maturity.

• In patients with observation alone as the intention to treat, 20% were braced during adolescence due to progression and another 10% underwent surgery

Danielsson AJ, Hasserius R, Ohlin A, Nachemson AL. Spine . 2007 15;32(20):2198-207.

Observation Versus Bracing: Web based review2007: Spine

• Multiple electronic databases were searched: limited to the English language: Eighteen studies were included (observation = 3, bracing = 15).

• Comparing the pooled rates for these two interventions shows no clear advantage of either approach. 

•  An evidence-based estimate of the risk of surgery will provide additional information to use as Option & weigh the costs and benefits of bracing.

Dolan Lori A.; Weinstein Stuart L.: Surgical Rates After Observation and Bracing for Adolescent Idiopathic Scoliosis: An Evidence-Based Review. SPINE 2007 : 32(19)S 91-100

Nighttime bracing• Prospective study: 102 consecutive female patients • Providence Night Brace • This is the first report of results of treatment with nighttime

brace made with CAD/CAM technology• Risser 0, 1, and 2- criteria for inclusion• High apex curves cephalad to T8 (n=31) success rate of

61% • Success rate of 79% (n = 71) if the apex was at or below

T9.• Providence brace effective in preventing progression

of AIS for curves <35 degrees. It was effective for larger curves with a low apex.

D'Amato CR, Griggs S, McCoy B. Spine. 2001: 15;26(18):2006-12.

Comparison of Brace versus Surgical Treatment: 2001

• ‘Radiologic Findings and Curve Progression 22 Years After Treatment for Adolescent Idiopathic Scoliosis: Comparison of Brace and Surgical Treatment With Matching Control Group of Straight Individuals’

• Although more than 20 years had passed since completion of the treatment, most of the curves did not increase. The surgical complication rate was low

• Degenerative disc changes were more common in both patient groups than in the control group.

Aina J.Danielsson, L. Nachemson, Alf et al Spine 2001: 26(5): 516-525

Standardization in study to avoid flaws: Optimal inclusion

criteria Future AIS brace studies should consist of:

• Age : 10 years or older when brace is prescribed • Risser 0-2, primary curve angles 25 degrees -40 degrees

• No prior treatment &• If female, either premenarchal or < 1 year postmenarche

SRS Committee on Bracing and Non-operative Management. 2005

Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Spine. 2005 5;30(18):2068-77. Review.

Assessment of brace effectiveness should include: 

1) The % of patients who have < 50 curve progression and the % of patients who have > 60 progression at maturity

2) The % of patients with curves > 450 at maturity and the % who have had surgery recommended or undertaken

3) 2 year follow-up beyond maturity to determine the % of patients who subsequently undergo surgery.

-All patients, regardless of compliance, should be included in the results (intent to treat).

-Every study should provide results stratified by curve type and size grouping

Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Spine. 2005 5;30(18):2068-77. Review.

SRS Committee on Bracing and Non-operative Management. 2005

BrAIST Trial2009

•  Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST),

• One of the first clinical trials in pediatric orthopedics

• Funded by the National Institutes of Health.

• 6 monthly follow up

• Anticipate to discover that bracing works for certain types of curves

• Much more selective in prescribing braces as a treatment

BrAIST Trial: INCLUSION CRITERIA

• Physical & Mental ability to adhere to bracing treatment

• BOYS /GIRLS• Pre/post menarche

no more than one year

• Outcome expected next year

• Washington University School of Medicine, St. Louis, Missouri

• The medical center is one of 25 sites across the United States and Canada participating in the trial

SURGEON VS ORTHOTISRestlessness with Over-enthusiastic Tubular vision syndrome ! Proponent of Brace

Breathless expectancy on Braces

Inborn Nihilism in Conservatism ?

 Balance

EVIDENCE BASED MEDICINE

UNREALISTIC UNREALISTIC

PRAGMATISM

TEAM

NO EBM: INTUITION

 

Source: Wheeless' Textbook of Orthopaedics

Rx Algorithm

Consensus 

• Only progressive pre-menarchal females with 25-35 degree curves or  250 - 3 00  curves within 1 year of menarche had >80% agreement on bracing. 

• Braces  in Adolescent  Idiopathic Scoliosis  (AIS)  treatment seem to produce stress; however there is controversy whether health related  quality  of  life  issues  of  brace  treated  adolescents  are affected negatively

     Aina  J.Danielsson, L. Nachemson, Alf et al. Spine:2007 – 32 (19): S91-S100 

Surgery

• Failed bracing• Curves >45 degrees• Unbalanced curves >40 degrees• Surgery is fusion with instrumentation

The future of AIS is with EBM

Controversies are Reducing and bottom lines are just evolving.

More recently, inclusion criteria have narrowed considerably to include primarily those most at risk for curve progression

Multi-centric randomized control trails are underway internationally for identifying Practices based on EBM

“Medicine is a science of uncertainty & an art of probability”