Status:
RECRUITING
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
Lead Sponsor:
GreenBone Ortho S.p.A.
Conditions:
Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06156904
Start Date
January 31 2024
End Date
October 1 2027
Last Update
June 7 2024
Active Locations (4)
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1
BG Klinikum Unfallkrankenhaus Berlin
Berlin, Germany, 12683
2
Trauma Surgery Department - University Hospital Regensburg
Regensburg, Germany, 93053
3
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
4
Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
Leeds, United Kingdom, LS13EX