OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

RecruitingOBSERVATIONAL
Enrollment

135

Participants

Timeline

Start Date

January 31, 2024

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2027

Conditions
Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
Interventions
DEVICE

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.

"All patients enrolled in this clinical investigation will undergo a reconstruction of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone as per the standard of care at the investigational sites. Patients will be treated with b.Bone which will be used as a bone substitute in isolation or as a graft expander to promote healing in the pelvis, upper and lower extremities.~b.Bone is a bone substitute without initial mechanical properties, therefore it is to be used in conjunction with internal/external fixation devices suitable for primary stabilization."

Trial Locations (4)

12683

RECRUITING

BG Klinikum Unfallkrankenhaus Berlin, Berlin

93053

RECRUITING

Trauma Surgery Department - University Hospital Regensburg, Regensburg

HU3 2JZ

RECRUITING

Hull University Teaching Hospitals NHS Trust, Hull

LS13EX

RECRUITING

Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary, Leeds

All Listed Sponsors
lead

GreenBone Ortho S.p.A.

INDUSTRY