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A New Regenerative Paradigm For Interval Autologous Cranioplasty: The Cell-Augmented Scaffold-Enhanced (CASE) Cranioplasty
Margarete Grace Knudsen, MD, Devin Barzallo, BA, Tiffany Hodges, MD, Brian Rothstein, MD, Christina Lorenzi, RN, Tyra Flugence, RN, Anand Kumar, MD, Edward Davidson, MD.
University Hospitals Cleveland Medical Center, Cleveland, OH, USA.

PURPOSE: Autologous interval cranioplasty has become the standard of care following decompressive craniectomy. Replantation of the stored bone graft has infection and bone resorption rates upwards of 30%. We propose a new paradigm for autologous cranioplasty incorporating novel regenerative techniques that aims to improve fidelity of grafts and reduce infection and resorption.
METHODS: An IRB-approved cohort of 11 consecutive patients who underwent Cell-Augmented Scaffold-Enhanced (CASE) regenerative cranioplasty were compared to 14 who underwent traditional autologous cranioplasty. All were followed for at least 6 months postoperatively. For the CASE cranioplasty, frozen autologous bone graft was thawed and washed in accordance with institutional protocol. Tenets of standard interval cranioplasty were followed. Cell-augmentation of the autologous bone graft scaffold was performed; channels were created in the diploic space, then packed with a 1:1 mixture of fresh autologous bone graft harvested from surrounding cranium and bone allograft. Traditional technique followed tenets of cranioplasty but without channeling nor cell augmentation. Primary outcome measures included post-operative graft infection, bone resorption after >6 months and need for graft explantation. Patient demographics and operative data were also collected. Quantitative statistics performed include Student’s independent t-test and Χ2 analysis with a significance level set to p = 0.05. Descriptive statistics include relative risks (RR) with 95% confidence interval (95%CI), means and standard deviations (SD).
RESULTS: Clinical evaluation for ≥ 6 months postoperatively demonstrated a bone graft infection rate of 0% for CASE subjects versus 14.3% (n=2) for traditional patients; RR for post-operative infection was 1.17 [95%CI 0.94-1.45]. No patients had bone resorption requiring reoperation or explantation from the CASE cohort, while 2 subjects (14.3%) from the traditional cohort required explantation (RR 1.17, 95%CI 0.94-1.45) due to graft infection. There was no statistically significant difference in gender, etiology, interval time from craniectomy to cranioplasty, nor dimension of defect between the groups. CASE subjects were found to be incidentally older (58 years vs 42, p = 0.02). Mean duration of surgery was 221.3min (SD±52.6min) for CASE subjects vs 119.9 (SD±53.6min) for traditional (p<0.01).
CONCLUSION: Cell-Augmented Scaffold-Enhanced cranioplasty represents a safe novel paradigm modification to standard autologous interval cranioplasty technique with reduced rates of post-operative infection and reoperation for explantation.


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