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NCT Number: NCT03841643

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

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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Key information

Conditions

Cranial Defect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department MKA, AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

cement

Device

norian cement for reconstruction of the cranial defect

Primary outcomes

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

    Time frame: within 10 days postoperative

Secondary outcomes

  1. ease of application of both biomaterials, as graded with a 0 to 10 VAS score by the treating physician

    Time frame: perioperative

  2. ease of application of both biomaterials, as determined by surgical time required

    Time frame: perioperative

  3. postoperative complications, as graded by CTCAE 4.0 by the treating surgeon

    Time frame: within 30 days postoperative

  4. patient satisfaction, as graded with a 0 to 10 VAS score

    Time frame: within 30 days postop

  5. postoperative complications, as graded by CTCAE 4.0 by the treating surgeon

    Time frame: at 6 months postop

  6. patient satisfaction, as graded with a 0 to 10 VAS score

    Time frame: at 6 months postop

  7. final implant position, as determined with CBCT

    Time frame: at 6 months postop

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study title

Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction: a Randomized-controlled Trial

Acronym: CRAN-PSI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2019
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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