Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03024008
PHASE1/PHASE2

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

Sponsor: BonusBio Group Ltd

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2017-07-27

Completion Date

2027-06

Last Updated

2025-12-10

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

BonoFill-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.

Locations (6)

Emek Medical Center

Afula, Israel

Barzilai Medical Center

Ashkelon, Israel

Hillel Yafe

Hadera, Israel

Carmel Medical Center

Haifa, Israel

Rambam Health Campus

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel