Clinical trial NCT06156904: OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
Official title: A Post-market Clinical Follow-up Investigation to Confirm the Performance and Safety of the Bone Substitute b.Bone in Extremities and Pelvis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
Lead sponsor: GreenBone Ortho S.p.A.
Sponsor class: INDUSTRY
First posted: 2023-12-05
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients both sexes requiring bone grafting with the synthetic bone substitute b.Bone, according to the standard clinical practice.

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.


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.

Primary outcomes:
measure: Performance of b.Bone by determining the radiographic healing/union after surgery.
timeFrame: 12 months
Secondary outcomes:
measure: Clinical outcomes measured by patient-reported outcomes - Pain
timeFrame: Baseline and 3, 6 and 12 months
measure: Clinical outcomes measured by patient-reported outcomes - Quality of Life
timeFrame: Baseline and 3, 6 and 12 months
measure: Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE
timeFrame: Up to 24 months
measure: Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions
timeFrame: Up to 24 months
Other outcomes:
measure: Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - bone formation
timeFrame: Up to 24 months
measure: Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - remodelling
timeFrame: Up to 24 months
measure: Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - material resorption
timeFrame: Up to 24 months
measure: Exploratory outcomes: Evaluate the performance of b.Bone on different anatomical sites of implantation.
timeFrame: Baseline and 3, 6 ,12, 24 months
Locations:
city: Berlin
country: Germany
facility: BG Klinikum Unfallkrankenhaus Berlin
city: Regensburg
country: Germany
facility: Trauma Surgery Department - University Hospital Regensburg
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: Leeds
country: United Kingdom
facility: Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
Study officials:
affiliation: Director of the Trauma Surgery Department University Hospital Regensburg, Germany
name: Volker Alt, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Honorary Consultant Trauma & Orthopaedic Surgery, Leeds General Infirmary, United Kingdom
name: Peter Giannoudis, Dr
role: PRINCIPAL_INVESTIGATOR
References: