Clinical trial NCT01661959: Adolescent Idiopathic Scoliosis Outcomes Database Registry
Official title: Scoliosis Outcomes Database Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Multi-center Database Registry
Spinal Deformity
Adolescent Idiopathic Scoliosis
Lead sponsor: Setting Scoliosis Straight Foundation
Sponsor class: OTHER
Collaborators: name: DePuy Spine
name: NuVasive
First posted: 2012-08-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.

Brief summary: The purpose of this study is to analyze the long-term outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic scoliosis.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in radiographic outcome for surgical treatment of idiopathic scoliosis.
timeFrame: 25 years
Secondary outcomes:
measure: Change in clinical outcomes for surgical treatment of idiopathic scoliosis.
timeFrame: 25 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Wilmington
country: United States
facility: Nemours Children's Clinic
state: Delaware
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Baltimore
country: United States
facility: John's Hopkins Medical Institute
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington Univ., St. Louis
state: Missouri
city: Camden
country: United States
facility: University Physicians
state: New Jersey
city: New York
country: United States
facility: Scoliosis Associates
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital, Cincinnati, OH
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Shriners Hospital for Children
state: Pennsylvania
city: Montreal
country: Canada
facility: CHU Saint-Justine Hospital
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
Study officials:
affiliation: Rady Children's Hospital San Deigo
name: Peter O Newton, MD
role: PRINCIPAL_INVESTIGATOR
References: