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

Biovico Sp. z o.o.29 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bone Diseases

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Qualified for bone defect filling procedures of various origins (e.g., bone void reconstruction following curettage of benign bone tumors, cysts, chondromas) * Age 18 to 75 years * Signed informed consent form Exclusion Criteria: * Acute or chronic inflammatory conditions in the surgical area * Systemic inflammatory and autoimmune diseases * Severe degenerative diseases * Confirmed hypersensitivity to product components * Skin inflammation or dermatological disease at the surgical site * Use of medications that may affect bone remodeling (e.g., bisphosphonates) * Use of corticosteroid-based medications * Participation in another clinical trial * Pregnancy or breastfeeding status

Outcomes

Primary Outcomes

Efficacy of Non-setting Paste in Bone Defect Remodeling at 12 Months

Success is defined as achieving Grade I (\>75% bone remodeling with \>75% material resorption) or Grade II (51-75% bone remodeling with 51-75% material resorption) according to the modified four-grade Neer classification system, assessed by radiographic examination with independent expert review.

Time frame: 12 months post-surgery

Secondary Outcomes

Safety profile assessment

Comprehensive monitoring of adverse events (AEs) and serious adverse events (SAEs) using the MedDRA classification system.

Time frame: Throughout 12-month study period

Bone remodeling progression at 6 weeks and 6 months

Assessment using modified Neer classification (Grade I-IV) by radiographic examination at 6 weeks and 6 months post-surgery to evaluate the progression of bone healing over time.

Time frame: 6 weeks, 6 months post-implantation

Patient Satisfaction

Evaluation of patient satisfaction with clinical trial participation and treatment outcomes using structured questionnaires.

Time frame: 12 months post-surgery

Treatment discontinuation rate

Number and percentage of patients who discontinue treatment due to device-related adverse events.