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

January 23, 2026 updated by: Biovico Sp. z o.o.

Safety and Efficacy of a 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-803
        • Department of Orthopaedics and Traumatology, Medical University of Gdansk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
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.
Device: Non-setting paste
Non-setting paste is injected into bone defects during surgical procedures for bone void reconstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout 12-month study period
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.
6 weeks, 6 months post-implantation
Patient Satisfaction
Time Frame: 12 months post-surgery
Evaluation of patient satisfaction with clinical trial participation and treatment outcomes using structured questionnaires.
12 months post-surgery
Treatment discontinuation rate
Time Frame: Throughout 12-month study period
Number and percentage of patients who discontinue treatment due to device-related adverse events.
Throughout 12-month study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biovico Sp. z o.o.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Actual)

November 12, 2025

Study Completion (Actual)

November 12, 2025

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.0 25.01.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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