Abstract
Objective
To evaluate the efficacy of a newly developed biomaterial, hydroxyapatite cement, for use in frontal sinus and anterior craniofacial skeletal reconstruction.
Design
A nonrandomized patient cohort that was compared with historical controls of standard treatment with methyl methacrylate implants.
Setting
Craniofacial reconstructive surgery services at 3 referral health care centers. Eligible patients had frontal-cranial defects limited to a maximum size of 25 cm 2 . Patients were randomly selected volunteers with preexistent, acute traumatic or acute surgically induced defects of the frontal sinus and anterior craniofacial skeleton. All patients provided informed consent, and the study was approved by the 3 institutional review boards. Forty patients underwent reconstruction of defects of the anterior craniofacial region, and 38 of these patients were evaluable at 24 months.
Main Outcome Measures
Hydroxyapatite cement was used to reconstruct full-thickness anterior craniofacial skull defects. Standard surgical techniques were used to place all implants. The primary outcome measurement was maintenance of implant volume determined at 24 months by computed tomography and clinical examination. Secondary outcome measures included incidence of complications and infections necessitating implant removal.
Results
Of the 38 evaluable patients, 31 had successful reconstructions at the end of the study, for an overall success of 82% for frontal sinus and frontofacial region reconstruction. Seven patients underwent explantation, 5 for surgical access to the site. Two implants were removed because of infection in the wound, for an overall incidence of approximately 5%. Explant biopsy specimens confirmed implant osseointegration and vascularization.
Conclusions
Hydroxyapatite cement successfully reconstructs full-thickness defects of the frontal sinus and frontofacial region at 24 months. Hydroxyapatite cement appears to be superior to acrylic implants for frontal-cranial reconstruction and by allowing implant osseointegration with improved biocompatibility.
Get full access to this article
View all access options for this article.