Cranial DefectPhase 3CRAN-PSINCT03841643
Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction
A Phase 3 study testing patient-specific implant and cement in people with Cranial Defect, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Defect
- What is being tested?
- patient-specific implant and cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jun 2017to 31 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- patient-specific implant, cement
- Keywords
- cranial reconstruction, cement, patient-specific implant, preprothetic surgery, atrophic jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-specific implantDevice
solid titanium implant that functions as a guiding template for harvesting, and as an implant for reconstruction of the cranial defect
cementDevice
norian cement for reconstruction of the cranial defect
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: patient-specific implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
volumetric measurement of cranial defect, through superimposition of the preoperative and postoperative cone beam computed tomography
Measured: 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
Measured: perioperative
ease of application of both biomaterials, as determined by surgical time required
Measured: perioperative
postoperative complications, as graded by CTCAE 4.0 by the treating surgeon
Measured: within 30 days postoperative
patient satisfaction, as graded with a 0 to 10 VAS score
Measured: within 30 days postop
postoperative complications, as graded by CTCAE 4.0 by the treating surgeon
Measured: at 6 months postop
patient satisfaction, as graded with a 0 to 10 VAS score
Measured: at 6 months postop
final implant position, as determined with CBCT
Measured: at 6 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start21 Jun 2017
- Primary completion1 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Neyt, AZ Sint-Jan AV
- Investigators
- Nathalie Neyt, MD, Principal investigator, maxillofacial department, AZ Sint-Jan Brugge-Oostende AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841643
- Sponsor's protocol ID
- 2146
- Acronym
- CRAN-PSI
- Status last verified
- Jun 2019
- First submitted
- 13 Feb 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT03841643
- Acronym / sponsor ID
- CRAN-PSI / 2146
- Conditions
- Cranial Defect
- Keywords
- cranial reconstruction, cement, patient-specific implant, preprothetic surgery, atrophic jaw
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C group | Active comparator | Device: cementIn 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. |
| P group | Experimental | Device: patient-specific implantIn the P group, the cranial bone defect will be reconstructed with a patient-specific implant (KLS Martin, Tuttlingen, Germany). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient-specific implantsolid titanium implant that functions as a guiding template for harvesting, and as an implant for reconstruction of the cranial defect | Device | P group |
| cementnorian cement for reconstruction of the cranial defect | Device | C group |
Primary outcome
volumetric measurement of cranial defect, through superimposition of the preoperative and postoperative cone beam computed tomography
Time frame: within 10 days postoperative
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Neyt, MD principal investigator
maxillofacial department, AZ Sint-Jan Brugge-Oostende AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing patient-specific implant and cement in people with Cranial Defect, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volumetric measurement of cranial defect, through superimposition of the preoperative and postoperative cone beam computed tomography (time frame: within 10 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.