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CranioplastyPhase 3OSTEOPRINTCRNCT06792864

Effectiveness of 3D Bone Matrix in Cranioplasty

A Phase 3 study testing OsteoprintCR and SMAR SET GMV Endurance Gentamicin in people with Cranioplasty and Craniotomy, run by Universidad Austral de Chile at 1 site in Chile.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The objective of this clinical trial is to evaluate the effectiveness of a 3D bone scaffold in relation to a scaffold formed by PCL + β-TCP (polycaprolactone and beta-tricalcium phosphate), compared to the use of PMMA (polymethyl methacrylate) acrylic cement for bone regeneration in patients undergoing cranioplasty in… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cranioplasty, Craniotomy, Craniotomy Clipping
What is being tested?
OsteoprintCR and SMAR SET GMV Endurance Gentamicin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChile
Study dates
1 Jul 2024to 1 Dec 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients between 18 and 70 years of age, with acquired skull defect from neurological surgeries such as:
  • craniocerebral trauma,
  • refractory intracranial arterial hypertension,
  • congenital cranial defects such as hydrocephalus or other similar surgically resolvable defects,
  • who are suitable for reconstruction using a PCL-TCP scaffold system;
  • patients or their guardians are capable of giving valid informed consent.

Who cannot join

  • Active infection at the time of study inclusion (in cases of chronic infection, active infections may manifest as a result of a failed trial of antibiotic withdrawal),
  • immunodeficiency such as:
  • HIV,
  • systemic corticosteroid therapy,
  • chemotherapy,
  • synchronous hematologic malignancy,
Show all 11Show fewer
  • other causes of secondary or primary immunodeficiency;
  • patients with uncontrolled chronic diseases such ascardiovascular, respiratory or immunological diseases,
  • psychiatric disorders not controlled with home pharmacotherapy,
  • Women currently pregnant, breastfeeding or planning to become pregnant within 2 years of reconstruction surgery,
  • patients with a life expectancy of less than 12 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chile1 site

  • Hospital Base de Valdivia

    Valdivia, 5110434

Other trials in Chile

About this study

Official title: Effectiveness of 3D Printed Polycaprolactone and Tricalcium Phosphate Bone Scaffold for Bone Regeneration in Cranioplasty: Randomized Clinical Trial

The objective of this clinical trial is to evaluate the effectiveness of a 3D bone scaffold in relation to a scaffold formed by PCL + β-TCP (polycaprolactone and beta-tricalcium phosphate), compared to the use of PMMA (polymethyl methacrylate) acrylic cement for bone regeneration in patients undergoing cranioplasty in the city of Valdivia, Chile, between the years 2024-2025.

The main beneficiaries will be patients, users of the public or private health system, who require bone regeneration. The intermediate beneficiaries are the health team: doctors specialized in surgery and orthopedics, dedicated in their professional work to bone reconstruction and regeneration.

Read the detailed description

The study will be a parallel-arm clinical trial (8 patients randomly divided into 2 groups), where the participants will be patients with cranial defects requiring cranioplasty at the Department of Neurosurgery of Base Hospital of Valdivia, Chile. Previously, data of each participant will be collected, such as sex, age, basic comorbidities and clinical diagnosis.

The outcome variables to be considered in this study are: The volume of bone reconstruction measure in axial computed tomography (CT) using the tool available in Mimics software delivering the value in cm3 , and the scaffold attachment to adjacent bone using the linear density scale in Hounsfield units (HU) where it will be considered from +3000 HU as dense bone formation and presence of GAP <1mm. The last variable will be the patients' perception of esthetics and quality of life, which will be measured using the "QOLIBRI" scale, where the items with the greatest difference in scores between the two groups will be highlighted; in addition, >80 total points will be considered as good quality of life.

Sample calculation: Considering the need to observe the maintenance of skull volume in functional and aesthetic aspects, according to the results of Park et al., the use of PCL/ß-TCP material observed a volume difference of 4.4 ± 2.5% at six months postoperatively versus the average initial volume, calculating the need for four study subjects per group (Effect size d= 1. 76; alpha error probability= 0.05; Power= 0.7; Allocation ratio N2/N1= 1. G*Power software U. Düsseldorf) An experimental group (PCL scaffold + β-TCP) and a control group (PMMA cement).

Surgical intervention PCL + β-TCP intervention protocol: Prior to surgery, the patient must answer a survey of concept of quality of life through the QOLIBRI guideline, followed by this the patient will undergo an initial CT scan where the necessary measurements of the bone defect will be performed to transfer this information to a graphic design software such as CAD 3D, the design and printing of the PCL + β-TCP segment will be performed in the Polymer Laboratory of the Universidad Austral de Chile, once obtained the digital files will be converted to a printable format (.gcode) compatible with fused deposition 3D equipment (FDM), using the Creality Ender-3 printer with PCL filament from Canada Filament Store with a diameter of 1.75 mm.

Subsequently, the prototype will be obtained where it will be verified that the graft has the required characteristics for each patient. Once this is approved, the sterilization protocol of the PCL+ß-TCP matrices will be carried out, which will be placed in a container with 70% ethanol and submerged for 15 minutes, after which time they will be placed on sterile absorbent paper to eliminate excesses. Finally, the scaffolds are exposed to UV light for 20 minutes. Finally, the matrices are packed. Then the surgery will be performed and a control CT scan will be taken 6 months after the intervention, together with the second QOLIBRI guideline.

PMMA surgical cement intervention protocol: The initial CT scan will be performed on each patient, then intraoperatively, the solid and liquid component of the PMAA cement will be mixed with enveloping movements until a homogeneous mass will be obtained that allows molding, With the surgical gloves moistened with physiological solution, the molding of the intraoperative PMMA platelet begins, taking the bone defect as a reference, looking for a thickness similar to the adjacent bone of the bone defect, previously, placing a latex patch (included with the PMMA prosthesis) protects the brain tissue. When the plate begins to increase its temperature during the exothermic polymerization process, it is removed from the surgical field and once the formed platelet is solid and cold, it is placed again in the bone defect, in order to adhere to the bone of the cranial calotte by means of a titanium fixation system. All patients are monitored in the intensive care unit for at least 24 hours in the immediate postoperative period, where a clinical and radiological (CT) follow-up will be performed to rule out ongoing clinical complications. Finally, a control CT scan will be taken 6 months after the intervention, together with the second QOLIBRI guideline.

Being tested
OsteoprintCR, SMAR SET GMV Endurance Gentamicin
Keywords
Calcium Phosphates, Polyesters, Printing, Three-Dimensional, Skull / diagnostic imaging, Skull / surgery, Tissue Scaffolds
Medical subject headings
Craniocerebral Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OsteoprintCRDevice

    Hybrid technique of 3D printed bone matrix based on polycaprolactone with tricalcium beta phosphate

  • SMAR SET GMV Endurance GentamicinDevice

    Patient undergoing cranioplasty with conventional technique using polymethylmethylmethacrylate-based surgical cement brand "SMAR SET GMV Endurance Gentamicin".

Study groups in NCT06792864
Study groupRoleWhat they receive
OsteoprintCRExperimentalHybrid technique of 3D printed bone scaffold based on polycaprolactone with beta-tricalcium phosphate
Receives: Device: OsteoprintCR
SMAR SET GMV Endurance GentamicinActive comparatorPatient submitted to cranioplasty with conventional technique using surgical cement based on polymethylmethylmethacrylate (PMMA) called "SMAR SET GMV Endurance Gentamicin".
Receives: Device: SMAR SET GMV Endurance Gentamicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volume of bone reconstruction through computed tomography

    Bone reconstruction volume: The CT scans (pre-surgery and 6 months post-surgery) will be compared using the Mimics software version 21.0 (Materialise NV, Leuven, Belgium) and the difference will be recorded in cm3.

    Measured: 6 months

  2. Matrix bonding to the bone by computed tomography

    The CT scans (pre-surgery and 6 months post-surgery) will be compared using the 3D Slicer software where specific areas of the tissue are selected, each pixel in the image has an associated density value that corresponds to a shade of gray which is known as the "Gray Scale" that discriminates the tissue densities in Hounsfield units (HU), a standardized scale based on the relative density of the tissues, comparing it with that of water (0 HU) and air (-1000 HU). Where it will be considered from +3000 HU as dense bone formation and presence of GAP <1mm.

    Measured: 6 months

Secondary outcomes (1)

  1. Perception of aesthetics and quality of life

    Quality of life survey (QOLIBRI scale) which will be carried out in person in 2 instances of the study (before and after 6 months after surgery).

    The perception of quality of life will be measured with the QOLIBRI (Quality of Life after Brain Injury) guideline, which is validated and translated into Spanish, has 6 items and a score range from 0 to 100, where 100 is the highest quality of life. The items with the greatest difference in scores between the two groups will be highlighted; in addition, >80 total points will be considered as good quality of life.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start1 Jul 2024
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06792864
Sponsor's protocol ID
ORD541/2023
Acronym
OSTEOPRINTCR
Status last verified
Jan 2025
First submitted
12 Jan 2025
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Hwang, K., Villavicencio, J.B. and Agdamag, A.M.P. (2021) 'Tissue Engineering and Regenerative Medicine Cranioplasty Using Polycaprolactone-Tricalcium Phosphate: Management and Treatment Outcomes', Neurosurgery Practice, 2(4), p. okab027. Available at: https://doi.org/10.1093/neuopn/okab027.

  • Zubillaga Rodríguez, I., Sánchez Aniceto, G. and Montalvo Moreno, J.J. (2007) 'Reconstrucción craneal con biomateriales: Revisión histórica y estado actual', Revista Española de Cirugía Oral y Maxilofacial, 29(2), pp. 79-89.

  • Park H, Choi JW, Jeong WS. Clinical Application of Three-Dimensional Printing of Polycaprolactone/Beta-Tricalcium Phosphate Implants for Cranial Reconstruction. J Craniofac Surg. 2022 Jul-Aug 01;33(5):1394-1399. doi: 10.1097/SCS.0000000000008595. Epub 2022 Mar 9.

    PubMed 35261367

  • Brachet A, Belzek A, Furtak D, Geworgjan Z, Tulej D, Kulczycka K, Karpinski R, Maciejewski M, Baj J. Application of 3D Printing in Bone Grafts. Cells. 2023 Mar 10;12(6):859. doi: 10.3390/cells12060859.

    PubMed 36980200

  • Gonzalez Matheus I, Hutmacher DW, Olson S, Redmond M, Sutherland A, Wagels M. A Medical-Grade Polycaprolactone and Tricalcium Phosphate Scaffold System With Corticoperiosteal Tissue Transfer for the Reconstruction of Acquired Calvarial Defects in Adults: Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2022 Oct 13;11(10):e36111. doi: 10.2196/36111.

    PubMed 36227628

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OsteoprintCR and SMAR SET GMV Endurance Gentamicin in people with Cranioplasty and Craniotomy, run by Universidad Austral de Chile at 1 site in Chile.

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 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: enrolling by invitation, as of the sponsor's last update on 27 Jan 2025. 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 Chile. 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?

This study is still under way. Results are not available in the source record yet.

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?

Volume of bone reconstruction through computed tomography (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06792864, which also lists 5 linked publications.

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 27 Jan 2025.

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