NCT07379008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Bone DiseasesBone CystsBone NeoplasmEnchondromatosisBone Defects

Keywords

Bone substituteBone defect reconstructionBenign bone tumorBone regenerationOsteoconductivityInjectable bone graftBone remodeling

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months post-surgery

Secondary Outcomes (4)

  • Safety profile assessment

    Throughout 12-month study period

  • Bone remodeling progression at 6 weeks and 6 months

    6 weeks, 6 months post-implantation

  • Patient Satisfaction

    12 months post-surgery

  • Treatment discontinuation rate

    Throughout 12-month study period

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

Non-setting pasteDEVICE

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

Study group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Traumatology, Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-803, Poland

Location

MeSH Terms

Conditions

Bone DiseasesBone CystsBone NeoplasmsEnchondromatosis

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesCystsNeoplasmsNeoplasms by SiteOsteochondrodysplasiasBone Diseases, Developmental

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, non-randomized, unblinded, single-arm clinical trial without a control group, focusing on safety and efficacy evaluation of the bone substitute material.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

February 28, 2023

Primary Completion

November 12, 2025

Study Completion

November 12, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)