Adolescent Idiopathic Scoliosis Outcomes Database Registry

1. The first aim of this Database Registry is to maintain a prospective multicenter series
of patients treated surgically for adolescent idiopathic scoliosis. Patients from
multiple scoliosis centers around the U.S., as well as a center in Germany, will be
enrolled with comprehensive analysis of the curve pattern being treated, as well as the
type of surgery performed. The outcome of each surgical treatment will be analyzed. This
will allow the frequency of various curve types to be determined, as well as the
frequency of various surgical approaches utilized for each curve pattern.

2. The second aim is to determine if operative outcomes vary based on the surgical approach
utilized in scoliosis correction. In this analysis, it is anticipated that specific
approaches can be identified to be most appropriate for given scoliotic curve patterns.
In addition, the variations within individual curve patterns will be analyzed, as will
specific variations in the surgical approach (e.g., distal level of instrumentation,
hooks versus screws, hook patterns, etc).

3. The third aim is to develop an algorithm to guide surgical decision making based on a
scoliosis curve classification scheme that will allow the surgeon to provide the best
overall outcome (radiographic, functional, cosmetic) for a given patient with idiopathic
scoliosis.

4. The fourth aim is to evaluate the long-term outcomes of surgical intervention in this
patient population.

5. The fifth aim is to maintain a prospective multi-center series of patients with
idiopathic scoliosis who have not undergone surgical correction of their deformity. The
long-term outcome of this patient population will be compared with the surgical patient
population.

6. The sixth aim is to develop a guide to help clinicians make a decision for optimal
surgical treatment of AIS curves based on patient-specific 3D information.

7. Factors that may influence intra and post-operative course will also be evaluated. Of
particular interest are patient specific factors (curve size, pre op characteristics
such as blood work and PFT testing) and their influence on intra-operative blood loss.

Inclusion Criteria:

- Patients aged ≥ 10 and ≤ 21 years at time of enrollment,

- male or female,

- diagnosis of idiopathic scoliosis for which surgery is recommended to prevent
progression of the curvature or to correct trunk disfigurement.

- Curve cobb of any magnitude - operative range

- Spina bifida Oculta is permitted

- Spondylolisthesis and Spondylolysis are permitted, as long as non-operative

- Non-operative idiopathic scoliosis patients:

- aged ≥ 10 and ≤ 21 years, male or female, curve cobb of ≥ 40º, for whom surgery
has been offered and the patient has elected not to proceed with surgery.

OR

- OPTIONAL BY SITE: aged ≥ 10 and ≤ 21 years, male or female, Curve cobb ≥ 30º and
skeletally mature (with maturity defined as Age: girls > 14 yrs; Boys > 16 yrs and Risser
of ≥ 4 Plus one of the following: Girls 2+ yrs post menarchal, boys shaving regularly, no
height change in at least 6 months.

Exclusion Criteria:

- Prior spinal surgery

- MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation)

- Neuromuscular or other serious co-morbidities

- Thoracogenic or cardiogenic scoliosis

- Associated syndrome or developmental delay

- Unable or unwilling to firmly commit to returning for required follow-up visits