Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)

  • STATUS
    Recruiting
  • participants needed
    25
  • sponsor
    GreenBone Ortho S.r.l.
Updated on 27 January 2023

Summary

Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects up to 6 cm using GreenBone Implant. After the surgery, the Patients will be monitored at pre-scheduled visits up to 12 months. Adverse events, pain, quality of life and functional parameters, as well as X-ray and CT scan, will be evaluated at scheduled follow-up visits. An independent Data Safety Monitoring Board (DSMB) will review the safety reports at regular intervals and Serious Adverse Events (SAE) as soon as reported, to protect Patients participating in the study. The initial phase of the study contemplates the treatment of bone defects up to 3 cm. An adaptive interim analysis will be performed when the first 7 Patients will have completed the 6-month follow-up visit. The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety), and provide one of the following recommendations to the Sponsor: a) to stop the study for unacceptable frequency and severity of adverse events or b) to continue the study up to 25 Patients recruited and to include at least 5 Patients with a longer bone defect (> 3 cm up to 6 cm).

Description

This is a pre-market multi-centre, international, open label, single-arm, study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for the treatment of long bone defect. Bone defects can result from malformation, high-energy traumatic events, bone resection due to different pathologies such as tumors or infections, or from the treatment of complex non-unions. Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. These types of treatment carry the risk of transferring disease from animals and/or humans to the patient; there is also a risk of host local allergic reaction. Bone substitutes are devoid of the above risks and therefore they could be used alternatively to xenografts and allografts. GreenBone is a ceramic resorbable bone scaffold that has very similar structure to bone. It can be produced in large quantities, shaped easily and sterilised without losing its properties. Consequently, it is an ideal substitute that could be used to fill bone defects. This study will assess the safety of using GreenBone treatment of long bone defects up to 6 cm. Moreover it will assess its capacity of promoting new bone formation. The investigators will recruit 25 patients with long bone defect and instead of bovine xenograft we will use the GreenBone implant for the long bone reconstruction. Patients will be followed up for 12 months in total.

Details
Condition Bone Substitutes, Bone Defect
Treatment surgical repair of long bone defects
Clinical Study IdentifierNCT03884790
SponsorGreenBone Ortho S.r.l.
Last Modified on27 January 2023

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