Pre-market Study to Evaluate Safety and Performance of GreenBone Implant

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 6, 2019

Primary Completion Date

April 29, 2022

Study Completion Date

December 19, 2022

Conditions
Bone Substitutes
Interventions
DEVICE

Iliac crest reconstruction surgery

When autologous bone graft is needed for the treatment of non-unions or bone defects, is harvested from the pelvic iliac crest. Harvested tricortical graft blocks are used to facilitate fusion of joints (ie pubis symphysis, sacroiliac joint), to structurally support metaphyseal areas of articular impaction injuries and to fill in metaphyseal bone voids. The GreenBone device, with its inherent physical and biomimic properties, possesses similar structural properties to bone, thus, being the ideal material to be used for the treatment of the bone defect (3- 4cm) induced from the harvested tricortical iliac crest, restoring therefore the pelvic anatomy and minimising the risk of chronic pain, haematoma formation and herniation of the abdominal contents.

Trial Locations (1)

LS13EX

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

All Listed Sponsors
lead

GreenBone Ortho S.p.A.

INDUSTRY

NCT03836404 - Pre-market Study to Evaluate Safety and Performance of GreenBone Implant | Biotech Hunter | Biotech Hunter