4.7 Article

Clinical Outcomes of 3D-Printed Bioresorbable Scaffolds for Bone Tissue Engineering-A Pilot Study on 126 Patients for Burrhole Covers in Subdural Hematoma

Journal

BIOMEDICINES
Volume 10, Issue 11, Pages -

Publisher

MDPI
DOI: 10.3390/biomedicines10112702

Keywords

chronic subdural hemorrhage; burrhole cover; cosmetic outcomes; polycaprolactone; bioresorbable

Funding

  1. Osteopore International Pte Ltd.

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This study explored the cosmetic and safety outcomes of the bioresorbable burrhole cover Osteoplug (TM)-C for burrhole craniostomy. The results showed that patients using Osteoplug (TM)-C had higher satisfaction and quality of life compared to those without a burrhole cover. The absence of a burrhole cover was associated with poorer aesthetic outcomes. There were no significant differences in other clinical outcomes between different types of burrhole covers.
Burrhole craniostomy is commonly performed for subdural hematoma (SDH) evacuation, but residual scalp depressions are often cosmetically suboptimal for patients. Osteoplug (TM), a bioresorbable polycaprolactone burrhole cover, was introduced by the National University Hospital, Singapore, in 2006 to cover these defects, allowing osseous integration and vascular ingrowth. However, the cosmetic and safety outcomes of Osteoplug (TM)-C-the latest (2017) iteration, with a chamfered hole for subdural drains-remain unexplored. Data were collected from a single institution from April 2017 to March 2021. Patient-reported aesthetic outcomes (Aesthetic Numeric Analog (ANA)) and quality of life (EQ-5D-3L including Visual Analog Scale (VAS)) were assessed via telephone interviews. Clinical outcomes included SDH recurrence, postoperative infections, and drain complications. Osteoplug (TM)-C patients had significantly higher satisfaction and quality of life compared to those without a burrhole cover (ANA: 9 [7, 9] vs. 7 [5, 8], p = 0.019; VAS: 85 [75, 90] vs. 70 [50, 80], p = 0.021), and the absence of a burrhole cover was associated with poorer aesthetic outcomes after multivariable adjustment (adjusted OR: 4.55, 95% CI: 1.09-22.68, p = 0.047). No significant differences in other clinical outcomes were observed between Osteoplug (TM)-C, Osteoplug (TM), or no burrhole cover. Our pilot study supports Osteoplug (TM)-C and its material polycaprolactone as suitable adjuncts to burrhole craniostomy, improving cosmetic outcomes while achieving comparable safety outcomes.

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