Safety and Efficacy of Non-Setting Paste in Bone Defect Reconstruction
NCT07379008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2026-01-30
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.
Conditions
- Bone Diseases
- Bone Cysts
- Bone Neoplasm
- Enchondromatosis
- Bone Defects
Interventions
- DEVICE
-
Non-setting paste
Non-setting paste is injected into bone defects during surgical procedures for bone void reconstruction.
Sponsors & Collaborators
-
Biovico Sp. z o.o.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-28
- Primary Completion
- 2025-11-12
- Completion
- 2025-11-12
Countries
- Poland
Study Locations
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