RecruitingPhase 1Phase 2NCT03024008

Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

Sponsor

BonusBio Group Ltd

Enrollment

40 participants

Start Date

Jul 27, 2017

Study Type

INTERVENTIONAL

Conditions

Bone Fracture

Summary

The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications: 1. Long and short bone extra-articular comminuted fracture 2. Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called BonoFill-II for people with bone fracture. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBonoFill-II

Surgery will be performed under local or general anesthetics according to the Investigator's and anesthesiologist discretion. A standard orthopedic approach will be made according to the fracture site.Then the transplantation of BonoFill-II into the fracture site and the fixation of the fracture by intramedullary nail or plate and screws or external fixator as required will be performed. internal fixation (plate and screws and intramedullary nails) will not be routinely removed. External fixators will be removed upon achievement of satisfactory bone union.