Implanet has announced the publication of a new white paper entitled “Correction of Adolescent Idiopathic Scoliosis in hypokyphotic patients using JAZZ sublaminar bands: preliminary results of a multricentric study using 3D reconstruction.” The study, from three institutions in France, presents clinical findings from a group of adolescents with hypokyphotic thoracic scoliosis treated with JAZZ sublaminar implants.
Implanet: White Paper on Jazz Sublaminar Bands
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The research was undertaken by the Departments of Pediatric Orthopedic Surgery at the Robert Debré (Paris), La Timone (Marseille) and Purpan (Toulouse) hospitals in France, and, says the company in the December 6, 2016 news release, “represents a key stage in the JAZZ system’s clinical validation and confirms both safety and efficacy in the treatment of hypokyphotic idiopathic scoliosis. The study followed a 35 patient consecutive series for an average of 34 months.”
“These results confirm the efficacy of combining the posteromedial translation technique with rigid chrome-cobalt rods, enabling sagittal alignment to be restored in hypokyphotic patients suffering from idiopathic scoliosis”, said Brice Ilharreborde, M.D., Ph.D. “The use of JAZZ sublaminar bands should be considered for these patients to reduce complication rates and, in particular, the risk of intra-operative failure of the concave screws as a result of pulling from the bone. Furthermore, the reduced number of implants used to adequately treat these deformities allows the cost of surgery and the risk of medullary complication to be reduced.”
Ludovic Lastennet, CEO of Implanet, told OTW, “Following institutional review board approval, a consecutive series of 43 hypokyphotic patients, operated for progressive scoliosis in three university teaching hospitals between June 2011 and May 2014, were retrospectively analyzed. Among these patients only eight were excluded because the personalized 3D reconstructions were not feasible. The 35 remaining patients offer a very satisfying follow-up of about 34 ± 8 months with no additional exclusion. Regarding analyzed data this number of patients provides sufficient statistical significance.”
“This white paper is the final publication of a documented analyses of clinical results with a 34-month average postoperative follow up. The JAZZ Implant technology platform is now a reference in the treatment of complex hypokyphotic thoracic scoliosis.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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