(06/08/2007)
New SpineCor study has been accepted and published by Journal of Pediatric Orhopedic in the June 2007 issue.
Below is an abstract:
Coillard C, Vachon V, Circo AB, Beausejour M, Rivard CH.
Effectiveness of the SpineCor Brace Based on the New Standardized Criteria Proposed by the Scoliosis Research Society for Adolescent Idiopathic Scoliosis.
J Pediatr Orthop. 2007 Jun;27(4):375-379.
The purpose of this prospective observational study was to evaluate the effectiveness of the Dynamic SpineCor brace for adolescent idiopathic scoliosis in accordance with the standardized criteria proposed by the Scoliosis Research Society Committee on Bracing and Nonoperative Management. They proposed these guidelines to make the comparison among studies more valid and reliable.
METHODS: From 1993 to 2006, 493 patients were treated using the SpineCor brace. Two hundred forty-nine patients met the criteria for inclusion, and 79 patients were still actively being treated. Overall, 170 patients have a definitive outcome. All girls were premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness included (1) percentage of patients who have 5 degrees or less curve progression, and percentage of patients who have 6 degrees or more progression; (2) percentage of patients who have been recommended/undergone surgery before skeletal maturity; (3) percentage of patients with curves exceeding 45 degrees at maturity (end of treatment); and (4) Two-year follow-up beyond maturity to determine the percentage of patients who subsequently underwent surgery. RESULTS: Successful treatment (correction, >5 degrees, or stabilization, +/-5 degrees) was achieved in 101 (59.4%) of the 170 patients from the time of the fitting of the SpineCor brace to the point in which it was discontinued. Thirty-nine immature patients (22.9%) required surgical fusion while receiving treatment. Two (1.2%) of 170 patients had curves exceeding 45 degrees at maturity. One mature patient (2.1%) required surgery within 2 years of follow-up beyond skeletal maturity. CONCLUSIONS: The conclusion drawn from these findings is that the SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 45 (95.7%) of 47 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing. Therapeutic study-investigating the results of treatment: level II.
(06/08/2007)
BRACING IN THE UNITED STATES
&
THE SRS INCLUSION AND ASSESSMENT CRITERIA FOR FUTURE BRACING AIS STUDIES
MAKING COMPARISON AMONG STUDIES MORE VALID AND RELIABLE
Spinal Orthoses
CTLSO
TLSO
Custom molded
Boston
Wilmington
DYNAMIC
Night time orthoses
Literature Problems
Inconsistent treatment criteria
Compliance:
↓ more mature patient
↓ males
other factors
Weaning criteria
Follow-up duration
Success criteria: Exclusion of non-compliance patients
Final curvature ≤5º, ≥6º, ≥10ｺ progression SRS INCLUSION CRITERIA
1. Age at bracing – 10 years and older
2. Primary curve 25-40 º
3. Risser sign 0, 1 or 2
4. No prior treatment
5. Females – Premenarchal or one year postmenarchal
6. Include all patients regardless of compliance (‘intent to treat’)
SRS ASSESSMENT CRITERIA % of curve progressed 5º or less; 6º or more at maturity
% of patients who progressed beyond 45º - % of patients that had surgery or recommended for surgery
- minimum 2 years follow-up after maturity for ‘successful’ patients
RESULTS
RESULTS 25 TO 40 DEGREES |
| | TLSO* | PROVIDENCE* | SpineCor§ |
Population | 48 (At 2 yrs follow-up) | 35 (At 2 yrs follow-up) | 47 (At 2 yrs follow-up) | 170 (At weaning point) |
≤ 5º progression Larger Number Indicates Better Results | 7 (15%) | 11 (31%) | 45 (96%) | 101 (59%) |
Progression ≥ 6º Smaller Number Indicates Better Results | 41 (85%) | 24 (69%) | 2 (4%) | 69 (41%) |
| Progressed ≥ 45º Smaller Number Indicates Better Results | 27 (56%) | 21 (60%) | 1 (2%) | 39 (23%) |
| Surgery Smaller Number Indicates Better Results | 38 (79%) | 21 (60%) | 1 (2%) | 39 (23%) |
* Janicki JA, Poe-Kochert C, Armstrong DG, Thompson GH. A Comparison of the Thoracolumbosacral Orthoses and Providence Orthosis in the Treatment of Adolescent Idiopathic Scoliosis: Results Using the New SRS Inclusion and Assessment Criteria for Bracing Studies. J Pediatr Orthop. 2007 Jun; 27(4):369-374.
§ Coillard C, Vachon V, Circo AB, Beausejour M, Rivard CH. Effectiveness of the SpineCor Brace Based on the New Standardized Criteria Proposed by the Scoliosis Research Society for Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2007 Jun; 27(4):375-379. |
CONCLUSION