Cranial Defect Clinical Trial
Official title:
Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction: a Randomized-controlled Trial
Background Cranial reconstruction after monocortical bonegraft harvesting remains a clinical
challenge for the maxillofacial surgeon. At present, there is no gold standard technique
advised. Patient-specific implants are gaining terrain in the field of craniofacial
reconstruction. Comparative studies on differences in success rates between different
biomaterials for application in craniofacial surgery are lacking.
Aims The primary objective is to evaluate, in terms of cosmetic result, the postoperative
successful outcome of patient-standardized implants for cranial reconstruction after
bonegraft harvesting for jaw augmentation of patients with severely atrophic jaw.
Design Patients considered eligible for cranial bone-augmentation of the severely atrophic
jaw, that provide their consent for participation in the trial, will be randomized at
recruitment into either the patient-specific implant (P) or cement (C) group. In the P group,
the cranial bone defect will be reconstructed with a patient-specific implant (KLS Martin,
Tuttlingen, Germany). In the C group, the cranial bone defect will be reconstructed with
HydrosetTM (Stryker, New Jersey, USA), calcium phosphate cement, according to the current
standard practice at the department.
Parameters representing ease of application of the biomaterial , postoperative complication
rate, cosmetic and functional outcome will be measured at fixed time-points during surgery
and postoperative follow-up. A cone-beam computed tomography (CBCT) scan of both the donor
(cranium) and receptor site (jaw) will be taken preoperatively, within 10 days postop, and 6
months post-operatively to measure biomaterial positioning.
Conclusions Systematic reviews demonstrate the need for randomized prospective studies
regarding implantable biomaterials used in facial reconstructive surgery. We hypothesize that
patient-specific implants provide more user-friendly alternatives to the standard care, with
better cosmetic results.
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