A Post-market Clinical Follow-up Investigation to Confirm the Performance and Safety of the Bone Substitute b.Bone in Extremities and Pelvis.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation. All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties. It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.

• Male or female patient ≥ 18 years old.

• Patients willing and able to attend the standard of care follow-up visits and procedures.

• Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.

Locations
Other Locations
Germany
BG Klinikum Unfallkrankenhaus Berlin
RECRUITING
Berlin
Trauma Surgery Department - University Hospital Regensburg
RECRUITING
Regensburg
United Kingdom
Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
RECRUITING
Leeds
Contact Information
Primary
Sonia Granados, MSc
sonia.granados@greenbone.it
+393450954463
Backup
Susanna Salvagno
susanna.salvagno@greenbone.it
+393497337442
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2027-10
Participants
Target number of participants: 135
Related Therapeutic Areas
Sponsors
Leads: GreenBone Ortho S.p.A.

This content was sourced from clinicaltrials.gov

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