Long Bone Clinical Trial, Ver. 3.0 dated 04/03/2020
Research type
Research Study
Full title
A pre-market, multi-center, international, open-label, single-arm study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for surgical repair of long bone defects
IRAS ID
261955
Contact name
Peter Giannoudis
Contact email
Sponsor organisation
GreenBone Ortho srl
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 17 days
Research summary
This is a 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. The long bones are the femur, the tibia and the fibula for the lower limbs; the humerus, the radius and the ulna for the upper limbs. 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. The long bone defect is usually reconstructed by filling the missing bone area with either autologous bone, or bone obtained from human donors (allograft). However, this carries the risk of transferring disease from humans to the patient, and there is the risk of harvesting related complications when autograft used. Man-made bone substitutes are devoid of such risks and can be used as an alternative to animal and human bone. The purpose of this study is to test the safety and performance of the GreenBone Implant, a ceramic bone substitute with a structure very similar to natural bone, when used for long bone defects. The GreenBone Implant is a resorbable device, which means that it can easily be incorporated into the surrounding natural bone.
The study will be carried out at several international research sites and will involve 25 patients with long bone defect. The reconstruction of their long bone defect will be performed using the GreenBone Implant instead of cow bone or human bone.
All patients will be followed up for 12 months after surgery. During this time, the safety and performance of the GreenBone Implant will be assessed by monitoring its capacity to promote new bone formation without causing local or systemic (widespread) reactions.REC name
Wales REC 6
REC reference
20/WA/0222
Date of REC Opinion
18 Nov 2020
REC opinion
Further Information Favourable Opinion