Brace Study

A review of Full-Time Idiopathic Scoliosis Bracing with The L.A. Brace™ and Comparative Outcomes

Gez Bowman C.O.

7/1/2016

Introduction

Scoliosis affects 2 to 4% of the U.S. population of which 0.3 to 0.5% progresses to the point of needing treatment [1-7]. Bracing is the most commonly prescribed non-surgical treatment for Idiopathic scoliosis [8-13]. Braces are most typically prescribed for curves between 20 and 40 degrees [13] or between 25 and 40 degrees [14-16], but can also be prescribed for larger curves [17,18]. Scoliosis braces are fitted on 30,000 children every year while 38,000 undergo scoliosis surgery [19]. Various designs of braces are utilized in the U.S. with the most commonly used full-time braces being the Boston Brace, Rosenberger Brace and Wilmington Brace [13]. However, in the U.S., because insurance companies categorize scoliosis bracing along with all other orthotic and prosthetic services, many different types of scoliosis braces are provided. These can be usually be dispensed by any contracted orthotics company and it does not need to be fitted by an orthotist who specializes in scoliosis bracing. 

Success with bracing is generally measured as being the prevention of progression of more than 5 degrees [2,3,12-16]; or the prevention of progression beyond bracing range (>=45 deg) [2,8,17,18,21,22]; or the prevention of progression to surgical referral (failure rate) [13,15,23,24]. Studies of different scoliosis bracing programs have produced widely varying results, ranging from no effect to significant effect [2,8,12,17,18,21-30]. More recently, the multi-center BRAIST study [13] concluded that bracing was an effective treatment for scoliosis showing a significant reduction in surgery rates from 52% for observation to 28% for bracing. Studies have also suggested that success with bracing can vary according to the time wearing the brace [13,15,17,18,21,24-27], the design of the brace [16,18,20-28] and the skill and experience of the orthotist [23,31,32].

The LA Brace™ is a somewhat newer rigid bracing system first reported by Kessler in 2008 [15]. The brace applies hyper-corrective three-dimensional corrections and voids in a manner similar to the principles described in European Cheneau bracing systems [33,34]. It is a custom made brace that utilizes the computer generated data acquisition system of Algorithm Generated Predictions (AGP) and computer generated modeling techniques of CAD/CAM [35]. This bracing system has been utilized for several years and is available in several centers throughout the US and Canada [36].

Method

To confirm the results of the LA brace presented by Kessler [15] and to compare the effectiveness of the LA brace with the more commonly prescribed bracing systems, a multi- patients survey was performed in which all patients fit with the LA brace in an 8-year span from 2006 to 2014. In total, 391 patients received the LA brace. All patients were fitted by the same orthotist, Gez Bowman CO.

Surveys with stamped addressed envelopes were sent to all patients (Exhibit A) and then six months later resent to those who had not responded.

Results

A total of 391 surveys were mailed to patients, of which 42 were returned with no forwarding address. Of the remaining 349 patients, 122 surveys were received at a return rate of 34.4%.

Of these 122 responses, 18 patients were still wearing their brace (14.8%) while 104 (85.2%) were no longer wearing the brace.

Compliance: Wearing time compliance was recorded slightly different from the standards set by Wiley et. al. [17] by taking into account that if the patient had, for an extended period of time, worn the brace less hours than their usual average. Patients were considered fully compliant if the patient (i) had worn the brace on average >= 18 hours per day AND (ii) had not gone more than 2 months of wearing it less than 16 hours per day. Patients were considered non-compliant if they had (i) worn their brace for less than 8 hours per day OR (ii) had worn the brace < 18 hours per day AND had gone at least 2 months of wearing the brace less than 8 hours per day. All other patients were considered to be partially compliant.

Number of braces: Some patients grew out of their brace and required a replacement brace. All patients received between 1 and 4 braces, with most only receiving 1 brace and the average number of braces received being 1.2.

Time to follow up: At the time of receipt of the surveys, 15 of 104 patients had been out of their brace for less than one year, 2 of 104 had been out of their brace for one to two years and the remaining 75 had been out of their brace more than two years. Of the 104 patients no longer wearing their brace, 16 patients reported having received surgery for their scoliosis (15.4%). A chart review of the 16 patients who reported having received surgery showed that five (5) patients did not meet the SRS criteria for bracing [14]. Four (4) patients’ curves were too large at onset (44 deg, 44 deg, 45 deg, and 54 deg), while one (1) patient did not have an idiopathic curve (scoliosis diagnosis considered secondary to spinal cord tumor).

The remaining 11 of 99 patients represent true brace failures for idiopathic scoliosis at a rate of 11.1%. Of these 11 patients, four (4) were non-compliant, four (4) were partially compliant, and three (3) were fully compliant per the guidelines stipulated above.

	Surgery	No Surgery	% Surgery
Total	11	88	11%
Non Compliant	4	15	21%
Partially Compliant	4	14	22%
Fully Compliant	3	59	5%

TABLE 1 – Survey Results

Discussion

The following issues with the study were identified. 1) While it is known that all curves were at least 25 degrees in magnitude (prescribing physician’s preferences), the exact magnitudes of each curve is unknown so a mean curve size at onset could not be calculated; 2) results are dependent on factual truths provided by patients in respect to their wearing habits; 3) study assumes the survey return rate for surgery patients is the same as that of non-surgery patients.

The BRAIST Study by Weinstein et.al [13] compared 146 patients with Adolescent Idiopathic Scoliosis (AIS) fit with various rigid braces at 25 different centers and compared with 96 patients who underwent observation only. All patients had a curve size at onset of 20 to 40 degrees. Treatment failure was measured as a curve that progressed to 50 degrees or greater. Failure was noted in 28% of braced patients and 52% of observation-only patients. However, failure was only gauged by whether a curve reached the 50-degree threshold, therefore a curve could potentially have progressed as much as 29 degrees (20 degrees to 49 degrees) and still be considered a statistical success. As stated by Weinstein et. al. [37] curves greater than 30 degrees are at risk of progression as an adult, therefore the ultimate failure number from the BRAIST study could easily be higher than the reported 28%.

The Gutman et. al. study [16] compared 146 patients with AIS fit with the rigid Boston Brace with 97 patients fit with the “dynamic” Spinecor Brace. All patients had a curve size at onset of 25 to 40 degrees. Treatment failure was measured by (1) progression of six degrees or more; (2) curves progressing to >= 45 degrees; (3) patients who progressed and were referred to surgery. With the “dynamic” Spinecor  Brace, 76% progressed six degrees or more, 51% progressed to >= 45-degrees and 39% were referred for surgery. With the Boston rigid brace 55% progressed six degrees or more, 37% progressed to >= 45-degrees and 30% were referred for surgery.

The Allington and Bowen study [38] reviewed 188 patients with AIS fit with the Wilmington rigid brace and compared full-time with part-time and with curve size at onset. Treatment failure was measured by progression of five degrees or more. Of the 98 full-time brace wearers 13 of 36 (36%) smaller curves (<30 degrees) and 36 of 62 (58%) larger curves (30-40 degrees) progressed five degrees or more. Combining both group 49 of 98 patients (50%) progressed.

The Spoonamore et. al. study [39] reviewed 71 AIS patients with an average curve size of 29 degrees fit with the Rosenberger rigid brace. Treatment failure was measured by (1) progression of 6 degrees or more (56%); (2) patients who progressed and were referred to surgery (30%).

The Kessler study [15] reviewed 40 patients with AIS fit with the LA rigid brace. All patients had a curve size at onset of 25 to 40 degrees. Treatment failure was measured by (1) progression of six degrees or more (15%); (2) curves progressing to >= 45 degrees (5%); (3) patients who progressed and were referred to surgery (5%).

From this outcomes study, of the 99 survey responses that were received from patients who were no longer wearing a brace and met the SRS bracing criteria, 11 patients stated they had received surgery for their scoliosis (11%).

 

	BRAIST	BRAIST	Gutman	Gutman	Allington	Spoonamore	Kessler	Bowman
	Observation	Various	SpineCor	Boston	Wilmington	Rosenberger	LA Brace	LA Brace
N	96	146	97	146	188	71	40	99
>5 deg Progression	—	—	76%	55%	50%	56%	15%	—
>=45 deg	—	—	51%	37%	—	—	5%	—
>=50 deg/Surgery	52%	28%	39%	30%	—	30%	5%	11%

TABLE 2 – Treatment Comparisons

A review of the 11 LA brace failures in this report categorized the patients into three groups:

1. A) Non-compliance with brace wearing requirements
2. B) Full time compliance with poor in-brace correction
3. C) All other reasons including partial compliance and/or moderate in-brace correction

Four (4) patients were determined to fit group A, three (3) patients fit group B, four (4) patients fit group C. As only three of the brace failures wore the brace full time, it is suggested that brace failure for patients who are fully compliant with their LA brace should be as low as 5%.

The 11% failure rate presented here is higher than that of Kessler’s paper describing a failure rate of 5% with the LA Brace [15]. However, the results appear to confirm the findings of Kessler [15] that the LA Brace represents a possibly more effective bracing alternative for scoliosis than the more commonly utilized scoliosis bracing systems with success rates between 89%  and 95% compared with the findings of 70% to 72% with other rigid bracing systems [13,16,39].

The results with the LA brace suggest that good outcomes are achievable for scoliosis patients who meet the SRS inclusion criteria if they are compliant with full-time bracing, are fitted with an effective bracing system and the fitting is performed by an orthotist skilled in the practice of scoliosis bracing. If these criteria are met, then the risk of progression to surgery can be as low as 5%.

 

References

1. Nachemson AL, Lonstein JE, Weinstein SL. Report of the Prevalence and Natural History Committee of the Scoliosis Research Society. Denver: Scoliosis Research Society, 1982.
2. Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis: a prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am 1995; 77:815-822.
3. Albanese SA. Idiopathic scoliosis: etiology and evaluation. Orthopaedic Knowledge Update Pediatrics. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2002. 287-96.
4. Lonstein JE. Adolescent idiopathic scoliosis. Lancet. 1994;344(8934):1407–1412….
5. Smith JR, Sciubba DM, Samdani AF. Scoliosis: a straightforward approach to diagnosis and management. JAAPA. 2008;21(11):40–45.
6. Reamy BV, Slakey JB. Adolescent idiopathic scoliosis: review and current concepts. Am Fam Physician. 2001;64(1):111–116.
7. Roach JW. Adolescent idiopathic scoliosis. Orthop Clin North Am. 1999;30(3):353–365, vii–viii.
8. Emans JB, Kaelin A, Bancel P, Hall JE, Miller ME. The Boston bracing system for idiopathic scoliosis. Spine 1986; 11:792-801.
9. Green NE. Part-time bracing of adolescent idiopathic scoliosis. J Bone Joint Surg Am 1986; 68:738-742.
10. Rowe DE, Bernstein SM, Riddick MF, Adler F, Emans JB, Gardner-Bonneau D. A meta-analysis of the efficacy of non-operative treatments for idiopathic scoliosis. J Bone Joint Surg Am 1997; 79:664-674.
11. Lonstein JE, Winter RB. The Milwaukee brace for the treatment of adolescent idiopathic scoliosis: a review of one thousand and twenty patients. J Bone Joint Surg Am 1994; 76-A: 1207-1221.
12. Winter RB, Lonstein JE, Drogt J, Noren CA. The effectiveness of bracing in the nonoperative treatment of idiopathic scoliosis. Spine 1986; 11:790-791.

13. Weinstein SL, Dolan LA, Wright JG, DobbsMB. Effects of Bracing in Adolescents with Idiopathic Scoliosis. N Engl J Med 2013;369:1512-21

14. Richards BS, Bernstein RM, D’Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2068-75; discussion 2076-7.
15. Kessler JI, Efficacy of a new computer-aided design/computer-aided manufacture orthosis in the treatment of adolescent idiopathic scoliosis. J Pediatr Orthop B. 2008; 17(4):207-11
16. Gutman G et. al. The effectiveness of the SpineCor brace for the conservative treatment of adolescent idiopathic scoliosis. Comparison with the Boston brace. Spine May 2016, Volume16 Issue5, 628-631
17. Wiley JW, Thomson JD, Mitchell TM, Smith BG, Banta JV. Effectiveness of the Boston brace in treatment of large curves in adolescent idiopathic scoliosis. Spine 2000; 25:2326-2332.
18. Katz DE, Durrani AA Factors that influence outcome in bracing large curves in patients with adolescent idiopathic scoliosis. Spine. 2001 Nov 1;26 (21):2354-61
19. Scoliosis.org, http://www.scoliosis.org/info.php Source: National Scoliosis Foundation, June 2007.
20. Katz DE, Richards BS, Browne RH, Herring JA. A comparison between the Boston brace and the Charleston bending brace in adolescent idiopathic scoliosis. Spine 1997; 22:1302-1312.
21. Bowen JR, Keeler KA. Pelegie S. Adolescent idiopathic scoliosis managed by a nighttime bending brace. Orthopedics 2001; 24:967-970.
22. Howard A, Wright JG, Hedden D. A comparative study of TLSO, Charleston, and Milwaukee braces for idiopathic scoliosis. Spine 1998; 23:2404-2411.
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; 27:369-374.
24. Spoonamore MJ1, Dolan LA, Weinstein SL. Use of the Rosenberger brace in the treatment of progressive adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2004 Jul 1;29(13):1458-64.
25. Bassett GS, Bunnell WP, MacEwen GD. Treatment of idiopathic scoliosis with the Wilmington brace. J Bone Joint Surg Am 1986; 68:602-605.
26. Katz DE, Herring JA, Browne RH, Kelly DM, Birch JG. Brace wear control of curve progression in adolescent idiopathic scoliosis. J Bone Joint Surg Am. 2010 Jun;92(6):1343-52.
27. Allington NJ, Bowen R. Adolescent Idiopathic Scoliosis: Treatment with the Wilmington Brace. A Comparison of Full-Time and Part-Time Use. J Bone Joint Surg Am, 1996 Jul; 78 (7): 1056 -62 .
28. Weiss HR, Weiss MR. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): A prospective trial comparing two different concepts. J Ped Rehab 2005 8:199-206
29. Goldberg CJ, Moore DP, Fogarty EE, Dowling FE (2001) Adolescent idiopathic scoliosis: the effect of brace treatment and the incidence of surgery. Spine 26:42–47
30. Dolan LA1, Weinstein SL. Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review.Spine 2007 Sep 1;32 (19 Suppl):S91-S100.
31. Moon M, Shaughnessy W, Stans A, Dekutoski M, Stoll S. Beneficial Effects of Orthotist Training on Bracing Success for Adolescent Idiopathic Scoliosis. Work performed at the Mayo Clinic, 200 1st St, SW, Rochester, MN 55905, Association of Children’s Prosthetic-Orthotic Clinics 2006 Annual Meeting, May 17-20, 2006
32. Cottolorda J, Kohler R. Garin C, Genevois P, Lecante C, Berge B. Orthoses for mild scoliosis: a prospective study comparing traditional plaster mold manufacturing with fast, noncontact 3-dimensiona! acquisition. Spine 2005; 30:399-405.
33. Pham VM, Houilliez A, Schill A, Carpentier A, Herbaux B, Thevenon A. Study of the pressures applied by a Chêneau brace for correction of adolescent idiopathic scoliosis. Prosthet Orthot Int. 2008;32:345–355.
34. Weiss HR, Rigo M. The Chêneau concept of bracing—actual standards. Stud Health Technol Inform.2008;135: 291–302
35. Bowman G. The L.A. Brace – Description and discussion. Physiotherapy Theory and Practice 2011; 27(1); 68-73
36. The LA Brace Co, https://thelabrace.com/availability.php
37. Weinstein SL, Dolan LA, Spratt KF, Peterson KK, Spoonamore MJ, Ponseti IV: Health and function of patients with untreated idiopathic scoliosis: A 50 year natural history study. JAMA. 2003, 289: 559-567
38. Allington NJ, Bowen R. Adolescent Idiopathic Scoliosis: Treatment with the Wilmington Brace. A Comparison of Full-Time and Part-Time Use. J Bone Joint Surg Am, 1996 Jul; 78 (7): 1056 -62 .
39. Spoonamore MJ1, Dolan LA, Weinstein SL. Use of the Rosenberger brace in the treatment of progressive adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2004 Jul 1;29(13):1458-64.