the spinecor dynamic corrective brace

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The

Dynamic Corrective Brace

SCIENTIFIC PUBLICATIONS


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Current results of the effectiveness SpineCor dynamic bracevs. Rigid bracing systems based on the new SRS inclusion

criteria for bracing studies.

Jeb McAviney* BSc, MChiro, MPainMed. Andrew Mills** MBAPO*The Ulster Spine Centre, Belfast, UK. **Sheffield Childrens Hospital, UK.

Introduction:

Adolescent Idiopathic Scoliosis is a serious condition affecting millions of childrenworldwide. Traditionally, rigid bracing techniques such as casting and TSLO (Boston) and

providence braces have been used to try to stop the progression of scoliosis to surgery. Theeffectiveness of orthotic management has been questioned and many surgeons no longer use

bracing, preferring a wait and see approach. As a result of this and in a quest to determinethe actual effectiveness of bracing on those cases most at risk of progression in 2005 thescoliosis research society published guidelines for the reporting of results from bracingstudies. This reporting is designed to allow comparison between cohorts and give a trueindication of the effectiveness of each intervention. Paper compares the result of the two

papers currently pushed using these guidelines.

The criteria were established by the SRS Brace Committee to standardize future studies andreporting on the non operative management of adolescent idiopathic scoliosis. Theyrecommend inclusion criteria for future adolescent idiopathic scoliosis brace studies toinclude: age of 10 years or older when brace is prescribed, Risser 0-2, primary curve angles

25 degrees -40 degrees, no prior treatment, and, if female, either premenarchal or less than 1year postmenarchal. Assessment of effectiveness should include the percentage of patientswith 6 degrees or greater progression at maturity, the percentage of patiet5ns with curves thatexceed 45 degrees at maturity and those that have surgery or surgery is recommended, and a2 year follow-up after maturity.

Research:

The June 2007 issue of Journal of Paediatric Orthopaedics published two papers on different bracing methods following the new SOSOC guidelines. The Thompson et al. paper studied

the TSLO and Providence braces and the Coillard et al. paper studied the SpineCor brace.

Methods: The rigid bracing paper was a retrospective comparative cohort study, SpineCor paper a prospective cohort study. Both studies followed standard treatment protocols for treatment of prescribed deceive, TSLO 22 hours, Providence 8-10 hours and SpineCor 20hours of wear. The rigid bracing paper had 83 subjects in which there were 48 patients in theTLSO group and 35 in the Providence group. There were 170 patients in the SpineCor group.


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Results:

There were no significant differences in age at brace initiation or initial primary curvemagnitude. There were slight differences in sex, with the percentage of girls treated in theSpineCor group was 92.7% vs TSLO 80% and Providence 84% . Initial Risser were very similar with the exception of riser 0 in the providence group. However in the results presented for the

providence group there was 11% unknown. It is possible that this group could be riser 0 whichwould make sense given the difficulty in establishing riser value prom pelvic x-ray and the factthat the average age for the providence group was 12.8 it is unlikely the riser value is at theupper end of the scale.

All of the 170 patients in the SpineCor group met the inclusion criteria and had results from beginning to end of bracing. As the SpineCor group is an active treatment group in a prospectivestudy, 47 of 170 had two year follow up results post bracing. However unlike the trend seen inrigid bracing where the majority of patients regress to their initial cob magnitudes and often

progress (as shown in the Thompson paper) the results of the SpineCor group were extremelystable with 95.7% maintaining or improving their correction two years after the end of bracing.Since the publication of these results in JPO it has been confirmed that these stable results areseen across the whole cohort making a comparison between the rigid bracing study and theSpineCor study possible.

Comparing results of SpineCor to TSLO shows that SpineCor was 4 times more effective thanTSLO (the main bracing treatment currently used across the world) in stopping progression of the scoliotic curve. When success is measured in avoiding surgery, SpineCor was 76.5%effective, and TSLO was 21% effective. The SpineCor was 71% more effective in stopping the

progression to surgery compared to TSLO.

Although 40.6% of patients in the SpineCor paper did show some progression of the scolioticcurve, only 1.2% progressed to a curve greater than 45 and most of these did not requiresurgery (unlike the TSLO group).

Comparing the Initial Cobb angle with the one at end of bracing

SCOLIOSIS CURVE TLSO SPINECOR Correction/Stabilisation 15% 59.4%Progression over 6 85% 40.6%Progression over 45 56% 1.2%

Progression to Surgery 79% 23.5%

Conclusion:

SpineCor is a more effective treatment than TSLO (Boston) bracing. Given that it can be provided to the patient at similar cost, with the same amount of radiological intervention, and itis not associated with the multiple side effects seen in rigid bracing, surgeons currently notrecommending bracing or using a rigid brace should consider using the SpineCor brace for the

benefit of their patients.


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