Skip to main content
OpenTrials
Completed

NCT Number: NCT07379008

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Diseases Bone Cysts Bone Defects Bone Diseases, Developmental Bone Neoplasm Bone Neoplasms Cysts Enchondromatosis Musculoskeletal Diseases Neoplasms Neoplasms by Site Osteochondrodysplasias

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics and Traumatology, Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-803, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-setting paste

Device

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

Primary outcomes

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

    Time frame: 12 months post-surgery

    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.

Secondary outcomes

  1. Safety profile assessment

    Time frame: Throughout 12-month study period

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

  2. Bone remodeling progression at 6 weeks and 6 months

    Time frame: 6 weeks, 6 months post-implantation

    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.

  3. Patient Satisfaction

    Time frame: 12 months post-surgery

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

  4. Treatment discontinuation rate

    Time frame: Throughout 12-month study period

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

Sponsors and collaborators

Lead sponsor

Biovico Sp. z o.o.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.