Study on Safety and Performance of AdvanCore Bone Void Filler

NCT06736457 | Recruiting

• 1 other identifier: ADV-01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

Conditions

Bone Fractures; Bone Defects; Bone Loss; Bone Graft

Keywords

Bone graft; Bone substitute; Bone regeneration; AdvanCore; Beta-Tricalcium Phosphate; Synthetic bone graft

Outcome Measures

Primary Outcomes (2)

• Freedom of bone reintervention (safety)

  The primary safety endpoint is defined as freedom of bone reintervention due to AdvanCore usage at 6 months, analyzing the occurrence of (S)AEs related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.

  6 months post-surgery

• Successful osteointegration (performance)

  The primary performance endpoint will analyze the AdvanCore integration at 6 months of surgery. This process is defined as osteointegration, which refers to the direct structural and functional connection of the living bone with the surface of the implant. The implant osteointegration will be assessed by imaging techniques selected according to the current clinical practices of each site. In this regard, the primary performance endpoint will be analyzed by considering the percentage of subjects with successful osteointegration at the defined timeline. AdvanCore will be considered successfully osteointegrated when the presence of fibrotic tissue surrounding the implant is not detected.

  6 months post-surgery

Secondary Outcomes (14)

• Evaluation of Adverse Events or Serious Adverse Events [(S)AEs] related to the procedure (safety)

  30-days post-surgery

• Evaluation of (S)AEs related to the procedure (safety)

  3 months post-surgery

• Evaluation of (S)AEs related to the procedure (safety)

  6 months post-surgery

• Evaluation of (S)AEs related to the procedure (safety)

  12 months post-surgery

• Evaluation of (S)AEs related to the device (safety)

  30 days post-surgery

Study Arms (3)

Long-bone injuries

EXPERIMENTAL

Group formed by subjects with long-bone injuries treated using AdvanCore blocks, wedges, or granules.

Procedure: AdvanCore bone grafting

Spine injuries

EXPERIMENTAL

Group formed by subjects with spine injuries treated using AdvanCore granules.

Procedure: AdvanCore bone grafting

Maxillofacial injuries

EXPERIMENTAL

Group formed by subjects with maxillofacial injuries treated using AdvanCore granules.

Procedure: AdvanCore bone grafting

Interventions

AdvanCore bone grafting PROCEDURE

AdvanCore medical device is implanted making sure that is in direct contact with all surfaces of the defect area.

Long-bone injuries; Maxillofacial injuries; Spine injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects ≥ 18 years old, male or female.
• Subjects who are eligible for a bone grafting/bone void filler procedure.
• Subjects with bone lesions beyond the limits of the bone's self-healing ability.
• Subjects, and/or an authorized representative, who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center.
• Subjects with only one fracture susceptible to treatment with an AdvanCore implant.

You may not qualify if:

• Subjects with any AdvanCore contraindication for implantation or use.
• Subjects with hypersensitivity to any of the AdvanCore components.
• Subjects with infections or soft/granulation tissue in the area to place bone graft.
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
• Women who are breastfeeding or of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).

Sponsors & Collaborators

• Artur Salgado SA: lead
• NAMSA: collaborator

Study Sites (4)

Unidade Local de Saúde do Alto Ave

Guimarães, Braga District, 4835-044, Portugal

RECRUITING

Unidade Local de Saúde de São João

Porto, Porto District, 4200-319, Portugal

NOT YET RECRUITING

Unidade Local de Saúde do Médio Tejo

Tomar, Santarém District, 2304-909, Portugal

NOT YET RECRUITING

Unidade Local de Saúde de Trás-os-Montes e Alto Douro

Lordelo, Vila Real District, 5000-508, Portugal

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Francisca C Costa

CONTACT

+351253794649; f.costa@artursalgado.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: May 29, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (4)