Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction (CRAN-PSI)

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.

Study Overview

• Status: Completed
• Conditions: Cranial Defect
• Intervention / Treatment: Device: cement; Device: patient-specific implant

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium
    • Department MKA, AZ Sint-Jan Brugge-Oostende AV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients aged 18 years or older
• patients of all genders
• patients with moderate to extreme bone atrophy of the jaw, caused by periodontitis or edentulism
• patients requiring a full reconstruction (both anterior and posterior region)
• patients receiving their surgery and follow-up care at the AZ Sint-Jan Brugge-Oostende AV
• patients providing written informed consent

Exclusion Criteria:

• - Patients not eligible according to abovementioned criteria
• Patients with severe uncontrolled diabetes
• Patients with contraindications for general anesthesia
• Patients with known allergies to the biomaterials used
• Patients with cranial vault without diploe and/or cranial vault thickness <3mm, as defined with cone-beam CT
• Patients with previous surgery of the skull region
• Patients with an explicit risk of bleeding from cranial venous structures, as described by the radiologist based on his/her evaluation of the preoperative CBCT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: C group; 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; norian cement for reconstruction of the cranial defect
Experimental: P group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
volumetric measurement of cranial defect, through superimposition of the preoperative and postoperative cone beam computed tomography	within 10 days postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
ease of application of both biomaterials, as graded with a 0 to 10 VAS score by the treating physician	perioperative
ease of application of both biomaterials, as determined by surgical time required	perioperative
postoperative complications, as graded by CTCAE 4.0 by the treating surgeon	within 30 days postoperative
patient satisfaction, as graded with a 0 to 10 VAS score	within 30 days postop
postoperative complications, as graded by CTCAE 4.0 by the treating surgeon	at 6 months postop
patient satisfaction, as graded with a 0 to 10 VAS score	at 6 months postop
final implant position, as determined with CBCT	at 6 months postop

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Nathalie Neyt, MD, maxillofacial department, AZ Sint-Jan Brugge-Oostende AV

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: cement; patient-specific implant; cranial reconstruction; preprothetic surgery; atrophic jaw
• Other Study ID Numbers: 2146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No