~ Vertebral Stapling ~
There is only one known study underway for vertebral body stapling on humans and I’m sure many are aware that this study is being led by Dr. Betz at the Shriner’s Hospital in Philadelphia. Other studies around the globe are being conducted on animal models.
I’m not too familiar with the process of getting FDA approval but the doctors walked on water to get this one through, considering they are able to perform experimental surgery on curves as low as 20 degrees! Parents are only too familiar with doctors discouraging treatment, other than "watching and waiting" ( if this could be called a treatment? ) and rarely prescribe braces for curves this small. Although most parents would prefer to prevent deformity in their children that could lead to disability later in life, many doctors refuse to prescribe user-friendly and low profile braces in the early stages and feel that an experimental surgery poses less of a risk?!
Accordingly, the device was
Exempt from FDA or corresponding national regulations because of retrospective IRB study of 510K approved device used off label for scoliosis
I had the opportunity to read the latest study on Vertebral Stapling published in January, 2010. The abstract is provided below.
Out of a possible 93 patients who underwent the procedure, only 29 were retrospectively reviewed at a follow-up of at least two years. Diagnosis was juvenile idiopathic scoliosis in 12 patients (42.9%) and adolescent idiopathic scoliosis in the remaining 16. One patient was lost to follow-up.
The authors state that the goal of bracing is to maintain pre-brace levels, which is generally the case for AIS but certainly not for juvenile idiopathic scoliosis, as many parents in the infantile and juvenile scoliosis group have seen significant curve reductions with serial casting and TLSO's. And no, I can't say there are compliance or psychological trauma issues as far as my daughter is concerned, although this is repeatedly mentioned in the study!
One has to wonder how many of the 93 patients progressed and *still* had to wear a brace after VBS or underwent spinal fusion surgery prematurely? This data is not readily available! Considering that the procedure is being marketed as an alternative to bracing, one would expect to see more detailed numbers showing actual results and not fuzzy vague statements like “within ten degrees of pre-op levels” and then calculated into the success figures for 30 % of the entire patient base!
Excerpt from Vertebral Body Stapling, R. Betz et. al., Spine Volume 35, Number 2, 1'1'169-176:
"Improvement" was defined as improvement in the preoperative Cobb angle of >10°, measured on the final follow-up radiograph. "No change" was defined as a +10° to -10° change in the preoperative Cobb angle (both values inclusive)
Progression was defined as worsening of the curve greater than 10°. Because the goal in this series was to see if stapling could be used as an alternative to bracing, "success" was defined as either improvement or no change on the final follow-up Cobb angle.
What results are actually being presented?! One could imagine or at least hope that these children who underwent VBS fared well. The pre-op curve for a child could be 28 degrees and two years post VBS surgery, a 38 degree curvature in this same child would be considered a success!
Table 4 on page 173 of the study lists 7 children whose curves improved slightly more than 10 degrees. However, in this group is a child whose curve was overcorrected to 25 degrees in the opposite direction! Another child (patient 22) was counted twice. Also, the authors do not address the issue of disc degeneration with VBS – which Braun et. al., found in the goat model and could spell spinal fusion surgery for *all* these children down the road.
A lot of questions surrounding VBS still remain unanswered and shrouded in secrecy. Parents are left wondering whether this procedure has any merit while others - desperate for a solution, subject their children to an experimental surgery.
Spine (Phila Pa 1976).2010 Jan 15;35(2):169-76.
Vertebral body stapling: a fusionless treatment option for a growing child with moderate idiopathic scoliosis.
Betz RR, Ranade A, Samdani AF, Chafetz R, D'Andrea LP, Gaughan JP, Asghar J, Grewal H, Mulcahey MJ
Shriners Hospitals for Children, Philadelphia, PA, USA. email@example.com
STUDY DESIGN: Retrospective review. OBJECTIVE: To report the results of vertebral body stapling (VBS) with minimum 2-year follow-up in patients with idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: While bracing for idiopathic scoliosis is moderately successful, its efficacy has been called into question, and it carries associated psychosocial ramifications. VBS has been shown to be a safe, feasible alternative to bracing for idiopathic scoliosis. METHODS: We retrospectively reviewed 28 of 29 patients (96%) with idiopathic scoliosis treated with VBS followed for a minimum of 2 years. Inclusion criteria: Risser sign of 0 or 1 and coronal curve measuring between 20 degrees and 45 degrees . RESULTS: There were 26 thoracic and 15 lumbar curves. Average follow-up was 3.2 years. The procedure was considered a success if curves corrected to within 10 degrees of preoperative measurement or decreased >10 degrees . Thoracic curves measuring <35 degrees had a success rate of 77.7%. Curves which reached < or =20 degrees on first erect radiograph had a success rate of 85.7%. Flexible curves >50% correction on bend film had a success rate of 71.4%. Of the 26 curves, 4 (15%) showed correction >10 degrees. Kyphosis improved in 7 patients with preoperative hypokyphosis (<10 degrees of kyphosis T5-T12). Of the patients, 83.5% had remaining normal thoracic kyphosis of 10 degrees to 40 degrees. Lumbar curves demonstrated a success rate of 86.7%. Four of the 15 lumbar curves (27%) showed correction >10 degrees. Major complications include rupture of a unrecognized congenital diaphragmatic hernia and curve overcorrection in 1 patient. Two minor complications included superior mesenteric artery syndrome and atelectasis due to a mucous plug. There were no instances of staple dislodgement or neurovascular injury. CONCLUSION: Analysis of patients with idiopathic scoliosis (IS) with high-risk progression treated with vertebral body stapling (VBS) and minimum 2-year follow-up shows a success rate of 87% in all lumbar curves and in 79% of thoracic curves <35 degrees. Thoracic curves >35 degrees were not successful and require alternative treatments
Correcting Scoliosis during the AIS
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