Effectiveness of 3D Bone Matrix in Cranioplasty

NCT06792864 | Enrolling By Invitation Phase 3 FDA Device

• 1 other identifier: ORD541/2023
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cranioplasty; Craniotomy; Craniotomy Clipping; Craniotomy Surgery; Craniocerebral Trauma; Craniocerebral Injuries

Keywords

Calcium Phosphates; Polyesters; Printing, Three-Dimensional; Skull / diagnostic imaging; Skull / surgery; Tissue Scaffolds

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (1)

• Perception of aesthetics and quality of life

  6 months

Study Arms (2)

OsteoprintCR

EXPERIMENTAL

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

Device: OsteoprintCR

SMAR SET GMV Endurance Gentamicin

ACTIVE COMPARATOR

Patient submitted to cranioplasty with conventional technique using surgical cement based on polymethylmethylmethacrylate (PMMA) called "SMAR SET GMV Endurance Gentamicin".

Device: SMAR SET GMV Endurance Gentamicin

Interventions

OsteoprintCR DEVICE

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

OsteoprintCR

SMAR SET GMV Endurance Gentamicin DEVICE

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

SMAR SET GMV Endurance Gentamicin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• immunodeficiency such as:
• HIV,
• systemic corticosteroid therapy,
• chemotherapy,
• synchronous hematologic malignancy,
• 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.

Sponsors & Collaborators

• Universidad Austral de Chile: lead

Study Sites (1)

Hospital Base de Valdivia

Valdivia, 5110434, Chile

Location

Related Publications (5)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 35261367 RESULT

• 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.

  PMID: 36980200 RESULT

• 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.

  PMID: 36227628 RESULT

Related Links

• A new method of cranioplasty
• Alloplastic Cranioplasty Reconstruction: A Systematic Review Comparing Outcomes With Titanium Mesh, Polymethyl Methacrylate, Polyether Ether Ketone, and Norian Implants in 3591 Adult Patients
• Clinical Application of Three-Dimensional Printing of Polycaprolactone/Beta-Tricalcium Phosphate Implants for Cranial Reconstruction
• Craneoplastía con implante de polimetilmetacrilato (PMMA) para corregir secuela de trauma. Reporte de caso
• Estudio de craneoplastía in situ empleando cemento de polimetilmetacrilato
• Implantes personalizados de polimetilmetacrilato (PMMA) para aplicaciones en craneoplastia
• Trauma craneoencefálico. Revisión de la literatura

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PCAravena

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 27, 2025
• Study Start: July 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)