Bone RegenerationNCT04773847
The Clinical and Radiographic Outcomes of a 3D-printed Patient-specific Biomimetic Bone Substitute in Maxillofacial Indications: an Interventional, Multi-centred, Open-label, Post-market Clinical Investigation.
A study testing Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D. in people with Bone Regeneration, run by Mimetis Biomaterials S.L..
Trial summary
The purpose of the study is to evaluate the clinical and radiographic outcome of MimetikOss 3D as a patient-specific bone substitute in regeneration of osseous defects in several maxillofacial indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Oct 2022
- Phase
- Interventional
- 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
- Male or female age 18 years or over at the time of inclusion into the study;
- Ability to obtain written informed consent from the recipient;
- Patients in need of craniomaxillofacial bone regeneration;
- Ability and capacity to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient;
- Patients with good general hygiene;
- Radiographic exam allowing a complete observation of the osseous defect;
- Mimetis approval of the feasibility.
Who cannot join
- Active tumour;
- Passive tumour with cancer recurrence within 10 years;
- Practice of intensive contact sport exercise during the clinical trial duration;
- Concomitant participation in other clinical trials;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
- Women who are breastfeeding;
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- Alcohol or drug abuse as noted in subject records or in subject history;
- Patients with a medical condition that may compromise the healing process or history of systemic diseases that would contraindicate the surgical treatment or any other disease that might have an influence on the involved tissues, such as: severe metabolic disorders, osteogenesis imperfecta, osteoporosis, infectious and degenerative bone diseases, immunodeficiency (congenital or acquired), autoimmune disease, Osler-Weber-Rendu syndrome, unbalanced diabetes, transient hypercalcemia, allergic disposition to phosphate calcium components, titanium or collagen etc; immunosuppressive therapy, steroid therapy, heparin treatment, corticoid treatment, treatments that interfere in the calcium-phosphate metabolism, bisphosphonate intake, Paclitaxel treatment, methotrexate medication etc);
- Acute and chronic infections in the surgery area (e.g. soft tissue infections, inflammatory and bacterial osteopathy, osteomyelitis) and / or mucosal diseases in the areas to be treated;
- In case of intraoral surgery, heavy smokers (>10 cigarettes) excluded;
- Inability to return for follow up visits.
Trial locations and contacts
No sites are listed yet.
Emilie Thorel contact
About this study
The purpose of the study is to evaluate the clinical and radiographic outcome of MimetikOss 3D as a patient-specific bone substitute in regeneration of osseous defects in several maxillofacial indications. The primary objective is to evaluate the capacity of MimetikOss 3D to perform bone substitute requirements, i.e long-term regeneration of bony tissue in complex defects without detrimental resorption. The secondary main objectives are to assess the versatility of MimetikOss 3D by the variety of maxillofacial sites regenerated and the surgical technique improvement (in terms of surgery duration, blood loss, ease-of-use of the product and surgeon satisfaction).
- Conditions
- Bone Regeneration
- Being tested
- Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.Procedure or surgery
Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.
| Study group | Role | What they receive |
|---|---|---|
| MimetikOss 3D | Experimental | Not described Receives: Procedure: Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric evolution of the grafted volume through radiological evaluation
Measured: 6 months post-surgery
Secondary outcomes (9)
Geometric evolution of the grafted volume through radiological evaluation
Measured: 12 months post-surgery
Versatility of MimetikOss 3D patient-specific bone substitute
MimetikOss 3D can be implanted to regenerate osseous defect from different indications of the maxillofacial area (dental area, jaw and maxilla reconstruction, zygomatic reconstruction and/or chin reconstruction for instance).
Measured: 12 months post-surgery
Incidence of serious adverse events and adverse events
Measured: during the surgery / 6 months post-surgery / 12 months post-surgery
Bone union observation
Measured: 12 months post-surgery
Surgical technique improvement in terms of accuracy of MimetikOss 3D design and positioning
Measured: directly after the surgery / 6 months post-surgery / 12 months post-surgery
Surgical technique improvement in terms of total surgery duration and duration of implantation of MimetikOss 3D
Measured: during the surgery
Surgical technique improvement in terms of blood loss measurement
Measured: during the surgery
Surgical technique improvement in terms of surgeon satisfaction
Measured: 12 months post-surgery
Aesthetic evaluation by visual observation of the symmetry of the face, pictures and/or irregular contours prosthetic palpable (if applicable)
Measured: directly after the surgery / 6 months post-surgery / 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Since the studied medical device is a custom-made product, only one group is considered.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mimetis Biomaterials S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Òscar Escuder i de la Torre, Principal investigator, University Hospital Parc Taulí Sabadell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773847
- Sponsor's protocol ID
- 2020/743
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Radiographic Outcomes of a 3D-printed Patient-specific Biomimetic Bone Substitute in Maxillofacial Indications: an Interventional, Multi-centred, Open-label, Post-market Clinical Investigation.
- ClinicalTrials.gov ID
- NCT04773847
- Acronym / sponsor ID
- 2020/743
- Conditions
- Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mimetis Biomaterials S.L.Industry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 26 Feb 2021 (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.
The purpose of the study is to evaluate the clinical and radiographic outcome of MimetikOss 3D as a patient-specific bone substitute in regeneration of osseous defects in several maxillofacial indications. The primary objective is to evaluate the capacity of MimetikOss 3D to perform bone substitute requirements, i.e long-term regeneration of bony tissue in complex defects without detrimental resorption. The secondary main objectives are to assess the versatility of MimetikOss 3D by the variety of maxillofacial sites regenerated and the surgical technique improvement (in terms of surgery duration, blood loss, ease-of-use of the product and surgeon satisfaction).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Since the studied medical device is a custom-made product, only one group is considered.
| Arm | Type | Receives |
|---|---|---|
| MimetikOss 3D | Experimental | Procedure: Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female age 18 years or over at the time of inclusion into the study;
- Ability to obtain written informed consent from the recipient;
- Patients in need of craniomaxillofacial bone regeneration;
- Ability and capacity to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient;
- Patients with good general hygiene;
Key exclusion criteria (11 listed)
- Active tumour;
- Passive tumour with cancer recurrence within 10 years;
- Practice of intensive contact sport exercise during the clinical trial duration;
- Concomitant participation in other clinical trials;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
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 |
|---|---|---|
| Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D. | Procedure or surgery | MimetikOss 3D |
Primary outcome
Geometric evolution of the grafted volume through radiological evaluation
Time frame: 6 months post-surgery
9 secondary outcomes
Geometric evolution of the grafted volume through radiological evaluation
Time frame: 12 months post-surgery
Versatility of MimetikOss 3D patient-specific bone substitute
Time frame: 12 months post-surgery
Incidence of serious adverse events and adverse events
Time frame: during the surgery / 6 months post-surgery / 12 months post-surgery
Bone union observation
Time frame: 12 months post-surgery
Surgical technique improvement in terms of accuracy of MimetikOss 3D design and positioning
Time frame: directly after the surgery / 6 months post-surgery / 12 months post-surgery
Surgical technique improvement in terms of total surgery duration and duration of implantation of MimetikOss 3D
Time frame: during the surgery
Surgical technique improvement in terms of blood loss measurement
Time frame: during the surgery
Surgical technique improvement in terms of surgeon satisfaction
Time frame: 12 months post-surgery
Aesthetic evaluation by visual observation of the symmetry of the face, pictures and/or irregular contours prosthetic palpable (if applicable)
Time frame: directly after the surgery / 6 months post-surgery / 12 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Yes
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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.
Emilie Thorel contact
Òscar Escuder i de la Torre principal investigator
University Hospital Parc Taulí Sabadell
Questions about this trial
What is this clinical trial studying?
A study testing Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D. in people with Bone Regeneration, run by Mimetis Biomaterials S.L..
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Thorel (+33672121897, emilie.thorel@mimetis.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric evolution of the grafted volume through radiological evaluation (time frame: 6 months post-surgery). 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 26 Feb 2021.