Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction

NCT03841643 | Completed Phase 3

• 1 other identifier: 2146
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cranial Defect

Keywords

cranial reconstruction; cement; patient-specific implant; preprothetic surgery; atrophic jaw

Outcome Measures

Primary Outcomes (1)

• volumetric measurement of cranial defect, through superimposition of the preoperative and postoperative cone beam computed tomography

  within 10 days postoperative

Secondary Outcomes (7)

• 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

Study Arms (2)

C group

ACTIVE COMPARATOR

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

P group

EXPERIMENTAL

In the P group, the cranial bone defect will be reconstructed with a patient-specific implant (KLS Martin, Tuttlingen, Germany).

Device: patient-specific implant

Interventions

patient-specific implant DEVICE

solid titanium implant that functions as a guiding template for harvesting, and as an implant for reconstruction of the cranial defect

P group

cement DEVICE

norian cement for reconstruction of the cranial defect

C group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Department MKA, AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Location

MeSH Terms

Interventions

Dental Bonding

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Nathalie Neyt, MD

  maxillofacial department, AZ Sint-Jan Brugge-Oostende AV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: maxillofacial surgeon, principal investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: June 21, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 31, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)