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

NCT06156904 | Recruiting DMC

• 1 other identifier: CIP-GB002-22-0123
• Study Type: observational
• Target: 135
• Locations: 2 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical outcomes measured by patient-reported outcomes - Pain

  Baseline and 3, 6 and 12 months

• Clinical outcomes measured by patient-reported outcomes - Quality of Life

  Baseline and 3, 6 and 12 months

• Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE

  Up to 24 months

• Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions

  Up to 24 months

Other Outcomes (4)

• Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - bone formation

  Up to 24 months

• Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - remodelling

  Up to 24 months

• Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - material resorption

  Up to 24 months

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. DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
• 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.
• Woman who is pregnant or breast-feeding.
• 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.

Sponsors & Collaborators

• GreenBone Ortho S.p.A.: lead

Study Sites (4)

BG Klinikum Unfallkrankenhaus Berlin

Berlin, 12683, Germany

RECRUITING

Trauma Surgery Department - University Hospital Regensburg

Regensburg, 93053, Germany

RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

RECRUITING

Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary

Leeds, LS13EX, United Kingdom

RECRUITING

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Granados, MSc

CONTACT

+393450954463; sonia.granados@greenbone.it

Susanna Salvagno

CONTACT

+393497337442; susanna.salvagno@greenbone.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: January 31, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

GB (2); DE (2)