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

Biovico Sp. z o.o.

Status: Completed

Conditions: Bone Neoplasm; Bone Cysts; Bone Diseases; Enchondromatosis; Bone Defects

Treatments: Device: Non-setting paste

Study type: Interventional

Funder types: Industry

Identifiers

NCT07379008

2.0 25.01.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Study group

Experimental group

Description:

A total of 29 patients, aged 18 to 75, who required bone defect filling following curettage of benign bone tumors or tumor-like lesions, underwent surgical implantation of a non-setting bone substitute paste to fill the resulting defects.

Treatment:

Device: Non-setting paste