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Study Links Preoperative Planning, Customized Implants to Fewer Spinal Surgery Complications

The pairing has been shown to facilitate a more harmonious and precise restoration of distal lumbar lordosis.

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By: Michael Barbella

Managing Editor

The aprevo Cervical interbody system being used intraoperatively. Photo: Carlsmed Inc.

A new retrospective study in the Global Spine Journal shows that 3D preoperative planning combined with patient-specific, anatomically designed interbody implants significantly reduces mechanical complication–related re-operations in complex adult spinal deformity (ASD) surgery.

“Previously published clinical data has demonstrated that 3D surgical planning combined with patient-specific interbody implants help surgeons achieve the personalized alignment goals and endplate fit that are unique to each patient,” Carlsmed CEO Mike Cordonnier said. “These new findings further validate the clinical value of personalization in spine surgery, improving outcomes, improving quality of life, reducing reoperations, and lowering the overall economic burden associated with revision procedures.”

The study compared two-year revision rates among ASD patients receiving Carlsmed Inc.’s aprevo personalized interbody implants with revision data from a similar patient cohort receiving conventional stock implants. The comparator cohort was drawn from the multicenter dataset of the International Spine Study Group, which is comprised of senior spine surgeons dedicated to advancing adult spinal deformity treatment. Patients treated with aprevo experienced significantly fewer revisions from mechanical complications, showing a revision rate of 4.3% (n=115) compared with 16.6% (n=997) using stock devices (p<0.001), representing a 74% relative reduction.

“In complex deformity cases where alignment accuracy is critical, translating preoperative goals into postoperative outcomes remains a persistent challenge,” said Justin Smith, M.D., Ph.D., Department of Neurosurgery, University of Virginia and the article’s lead author. “When paired with 3D preoperative planning, patient-specific interbody implants can facilitate a more harmonious and precise restoration of distal lumbar lordosis, which has been shown to decrease the risk of developing proximal junctional kyphosis, a significant and potentially devastating mechanical complication in ASD surgery.”

Carlsmed’s aprevo Technology Platform combines artificial intelligence (AI)-enabled preoperative planning with patient-specific interbody implants to enable predictable alignment tailored to individual patient anatomy and pathology, addressing alignment challenges and overcoming clinical and economic limitations inherent to traditional, stock implants.

“The revision rates in the comparator cohort are already relatively low, as these patients were treated by highly experienced and renowned surgeons,” stated study author Sigurd Berven, M.D., Department of Orthopedic Surgery, University of California-San Francisco. “Across four published studies noted in the paper, the average two-year revision rate due to mechanical complications is 24.9%, which makes the improvement achieved with aprevo even more meaningful.”

The peer-reviewed article is titled, “Personalized Spine Surgery in Adult Deformity: Reoperation Rates and Mechanical Complications Following Customized Planning and Interbody Implant Use.”

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions designed to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. 

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