OSsIRIS Study Version 00, 14 June 2023
Research type
Research Study
Full title
A post-market clinical follow-up investigation to confirm the performance and safety of the bone substitute b.Bone in extremities and pelvis.
IRAS ID
332064
Contact name
Peter Giannoudis
Contact email
Sponsor organisation
GreenBone Ortho SpA
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
b.Bone is as CE-marked medical device for use as a bone substitute for voids or gaps in the extremities and pelvis. It is a ceramic absorbable scaffold with a geometrical structure, engineered to reflect anatomical and physiological bone hierarchical structures. b.Bone scaffold is made of biomimetic substituted calcium phosphate phases (HA and β-TCP and minerals).
The proposed post-market clinical follow-up investigation will allow the collection of real-world clinical outcomes for b.Bone in patients who are implanted with the b.Bone device in a standard clinical environment.
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
It is planned to enroll 135-193 patients from approximately 15 EU and UK sites. Adult patients both sexes requiring bone grafting with the synthetic bone substitute b.Bone, according to the standard clinical practice.
Patients enrolled in this clinical investigation will undergo an orthopedic surgery with b.Bone as recommended by the specialist and according to orthopedic standard procedures. Patients will be evaluated preoperatively and at different timepoints after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients that require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0208
Date of REC Opinion
16 Oct 2023
REC opinion
Further Information Favourable Opinion