GreenBRIC Clinical Trial, v 01, 18/04/2018
Research type
Research Study
Full title
A Pre-Market, multi-center, national, open-label, single-arm Study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for Iliac Crest reconstruction following bone graft harvesting for pelvic fusion
IRAS ID
246763
Contact name
Peter Giannoudis
Contact email
Sponsor organisation
GreenBone Ortho srl
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
This is a pre-market multi-centre, national – open label, single-arm, study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for iliac crest reconstruction following bone graft harvesting for pelvic fusion. During pelvic fusion a considerable part of the iliac crest is removed and it is used as autologous bone graft for the fusion of the pubis symphysis. The bone defect that is formed in the iliac crest is usually filled with bone obtained from the cows (bovine xenograft) and or human donors (allograft). This carries 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. \nGreenBone 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 to reconstruct iliac crest defects. Moreover it will assess its capacity of promoting new bone formation. We will recruit 15 patients who will undergo pelvic fusion and instead of bovine xenograft we will use the GreenBone implant for the iliac crest reconstruction. Patients will be followed up for 6 months in total. Safety will be evaluated by monitoring local and potential systemic reactions; its bone forming capacity will also be assessed by its integration into the iliac crest.\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0218
Date of REC Opinion
20 Sep 2018
REC opinion
Further Information Favourable Opinion