A Phase 3 interventional study of patient-specific implant and cement in Cranial Defect, sponsored by AZ Sint-Jan AV. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by AZ Sint-Jan AV · Phase 3, Interventional, and Treatment
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.
AZ Sint-Jan AV is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: cement
In the P group, the cranial bone defect will be reconstructed with a patient-specific implant (KLS Martin, Tuttlingen, Germany).
Device: patient-specific implant
solid titanium implant that functions as a guiding template for harvesting, and as an implant for reconstruction of the cranial defect
norian cement for reconstruction of the cranial defect
volumetric measurement of cranial defect, through superimposition of the preoperative and postoperative cone beam computed tomography
Time frame: within 10 days postoperative
ease of application of both biomaterials, as graded with a 0 to 10 VAS score by the treating physician
Time frame: perioperative
ease of application of both biomaterials, as determined by surgical time required
Time frame: perioperative
postoperative complications, as graded by CTCAE 4.0 by the treating surgeon
Time frame: within 30 days postoperative
patient satisfaction, as graded with a 0 to 10 VAS score
Time frame: within 30 days postop
postoperative complications, as graded by CTCAE 4.0 by the treating surgeon
Time frame: at 6 months postop
patient satisfaction, as graded with a 0 to 10 VAS score
Time frame: at 6 months postop
final implant position, as determined with CBCT
Time frame: at 6 months postop
Plan to share: No
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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AZ Sint-Jan AV