NCT07379008

Safety and Efficacy of Non-Setting Paste in Bone Defect Reconstruction

Safety and Efficacy of a Non-Setting Paste in Bone Defect Reconstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Biovico Sp. z o.o. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and efficacy of a novel bone substitute material for the treatment of bone defects in patients requiring defect filling following the excision of benign bone tumors, cysts, or similar lesions. A total of 29 patients will undergo surgical intervention during which the bone substitute paste is applied to the defect site. Patients will be followed for 12 months, with radiographic assessments to monitor bone healing. The primary objectives of the study are to assess the adequacy of bone regeneration and to evaluate the safety profile of the material.

Detailed description

This prospective, non-randomized, unblinded clinical trial evaluates a non-setting paste for bone defect reconstruction. The study is conducted at two centers in Poland (Gdańsk and Zgorzelec). The study enrolls 29 patients aged 18-75 years who require bone defect filling following curettage of benign bone tumors and tumor-like lesions (cysts, chondromas, enchondromas). Patients with inflammatory conditions, autoimmune diseases, hypersensitivity to any components, or those using medications affecting bone remodeling are excluded. Bone remodeling is assessed radiologically at 6 weeks, 6 months, and 12 months using the modified four-grade Neer classification. Success is defined as achieving Grade I (\>75% remodeling) or Grade II (51-75% remodeling) at 12 months. Secondary endpoints include safety monitoring and patient satisfaction.

Conditions

• Bone Diseases
• Bone Cysts
• Bone Neoplasm
• Enchondromatosis
• Bone Defects

Interventions

Type	Name	Description
DEVICE	Non-setting paste	Non-setting paste is injected into bone defects during surgical procedures for bone void reconstruction.

Timeline

• Start date: 2023-02-28
• Primary completion: 2025-11-12
• Completion: 2025-11-12
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: Poland