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

NCT ID: NCT06156904

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2027-10-31

Brief 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.

Conditions

Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Male or female patient ≥ 18 years old.

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

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

Exclusion Criteria

1. Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone

2. Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.

3. Woman who is pregnant or breast-feeding.

4. Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GreenBone Ortho S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volker Alt, Dr

Role: PRINCIPAL_INVESTIGATOR

Director of the Trauma Surgery Department University Hospital Regensburg, Germany

Peter Giannoudis, Dr

Role: PRINCIPAL_INVESTIGATOR

Honorary Consultant Trauma & Orthopaedic Surgery, Leeds General Infirmary, United Kingdom

Locations

BG Klinikum Unfallkrankenhaus Berlin

Berlin, , Germany

Site Status: RECRUITING

Trauma Surgery Department - University Hospital Regensburg

Regensburg, , Germany

Site Status: RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, , United Kingdom

Site Status: RECRUITING

Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary

Leeds, , United Kingdom

Site Status: RECRUITING

Countries

Germany; United Kingdom

Central Contacts

Sonia Granados, MSc

Role: CONTACT

sonia.granados@greenbone.it

+393450954463

Susanna Salvagno

Role: CONTACT

susanna.salvagno@greenbone.it

+393497337442

Facility Contacts

Nikolai Spranger, Dr

Role: primary

nikolai.spranger@ukb.de

Volker Alt, Dr

Role: primary

volker.alt@ukr.de

Hermant Sharma, Dr

Role: primary

hemant.sharma5@nhs.net

Peter Giannoudis, Dr

Role: primary

peter.giannoudis@nhs.net

Other Identifiers

CIP-GB002-22-0123

Identifier Type: -

Identifier Source: org_study_id