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FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.

NCT07209033 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-12

No results posted yet for this study

Summary

The aim of this clinical study is to evaluate the efficacy, safety and long-term (radiological and clinical) outcomes during comprehensive care continuum of implanted biocomposite for bone regeneration FlexiOss® compared to the current standard of care in patients with primary acute trauma bone defects.

The efficacy, safety and long-term (radiological and clinical) evaluation will be assessed during follow up visits at 2, 6 weeks, 3, 6, 12 and 24 months.

Conditions

  • Bone Defect

Interventions

DEVICE

FlexiOss®

Bone reconstruction with FlexiOss® biocomposite.

PROCEDURE

Allogenic human bone grafting

Implantation of allogenic human bone graft.

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Medical Inventi S.A.

    lead INDUSTRY

Principal Investigators

  • Rafał Kamiński, Professor · Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP

  • Amadeusz Skiba, PhD · 5 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2028-03-31
Completion
2028-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209033 on ClinicalTrials.gov