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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 135

Contacts and Locations

• Study Contact: Name: Susanna Salvagno; Phone Number: +393497337442; Email: susanna.salvagno@greenbone.it
• Study Contact Backup: Name: Sonia Granados, MSc; Phone Number: +393479747691; Email: sonia.granados@greenbone.it

Study Locations

• Germany
  • Regensburg, Germany
    • Recruiting
    • Trauma Surgery Department - University Hospital Regensburg
    • Contact: Volker Alt, Dr; Email: volker.alt@ukr.de
• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust
    • Contact: Hermant Sharma, Dr; Email: hksorth@yahoo.co.uk
  • Leeds, United Kingdom, LS13EX
    • Not yet recruiting
    • Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
    • Contact: Peter Giannoudis, Dr; Email: peter.giannoudis@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of b.Bone by determining the radiographic healing/union after surgery.	Number and rate of patients with successful bone healing/union observable by X-ray or CT scan. Radiologic images will be evaluated by the surgeon according to the modified radiographic Union Scale for Tibial fractures (mRUST) classification or the modified Neer classification when applicable.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE	Number and rate of procedure and device-related adverse events (AEs) and Serious adverse events (SAEs) during the clinical investigation period.	Up to 24 months
Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions	Rate of reinterventions related to the treatment applied during the clinical investigation	Up to 24 months
Clinical outcomes measured by patient-reported outcomes - Pain	Change in the patient-reported pain using the Visual Analoge Scale from baseline to month 3, month 6 and month 12 post-treatment. Patient-completed questionnaire scoring pain by using 10 cm line. Zero (0) indicates no pain at all and ten (10) the worst pain ever.	Baseline and 3, 6 and 12 months
Clinical outcomes measured by patient-reported outcomes - Quality of Life	Change in the patient-reported Quality of Life assessed by Health Questionnaire from baseline to month 3, month 6 and month 12 post-treatment.	Baseline and 3, 6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - bone formation	Change of bone formation observable by X-ray/CT scan from the first evaluation immediately after b.Bone implantation through the observational period until the last available X-ray/CT scan.	Up to 24 months
Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - remodelling	Change of remodelling observable by X-ray/CT scan from the first evaluation immediately after b.Bone implantation through the observational period until the last available X-ray/CT scan.	Up to 24 months
Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - material resorption	Change of material resorption observable by X-ray/CT scan from the first evaluation immediately after b.Bone implantation through the observational period until the last available X-ray/CT scan.	Up to 24 months
Exploratory outcomes: Evaluate the performance of b.Bone on different anatomical sites of implantation.	b.Bone performance on different subsets of patients depending on the anatomical site of implantation: subset a: pelvis; subset b: upper extremities; subset c: lower extremities (The performance will be assessed as defined for the primary and secondary outcomes)	Baseline and 3, 6 ,12, 24 months

Collaborators and Investigators

• Sponsor: GreenBone Ortho S.p.A.
• Investigators: Principal Investigator: Volker Alt, Dr, Director of the Trauma Surgery Department University Hospital Regensburg, Germany; Principal Investigator: Peter Giannoudis, Dr, Honorary Consultant Trauma & Orthopaedic Surgery, Leeds General Infirmary, United Kingdom

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CIP-GB002-22-0123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No