Status:
COMPLETED
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant
Lead Sponsor:
GreenBone Ortho S.p.A.
Conditions:
Bone Substitutes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site. The other remaining patients...
Detailed Description
This is a pre-market multi-centre, national, open label, single-arm, study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for iliac crest reconstruction follo...
Eligibility Criteria
Inclusion
- Male or female Patients.
- Patients aged ≥ 18 and ≤ 70 years old.
- Patients requiring iliac crest reconstruction secondary to pelvic fusion.
- Patients understanding the nature of the study and providing their informed consent to participation.
- Patients willing and able to attend the visits and procedures foreseen by study protocol.
Exclusion
- Patients with bone infections at the time of enrolment.
- Patients with bone malignant tumor(s) at the time of enrolment.
- Patients who have been treated with chemotherapy or radiotherapy within 12 months before the study enrolment.
- Patients with concomitant infectious systemic diseases at the time of enrolment.
- Patients with known inflammatory systemic diseases at the time of enrolment.
- Patients with concomitant myeloproliferative disorders at the time of enrolment.
- Patients currently treated with systemic immunosuppressive agents, including steroids.
- Patients with active autoimmune disease.
- Patients with coagulopathy or bleeding disorders.
- Patients who have received a previous treatment of bone substitution in the same anatomical site.
- Patients with known or suspected allergy or hypersensitivity to the GreenBone Implant components.
- Patients who are participating or have participated in any other conflicting studies within the 30 days before the study enrolment. (This does not include patients who have taken part in other non-conflicting non-interventional or observational studies.
- These patients may still be eligible).
- Pregnant women and/or women that intend to be pregnant within 6 or 12 months from surgery.
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03836404
Start Date
March 6 2019
End Date
December 19 2022
Last Update
June 7 2024
Active Locations (1)
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1
Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
Leeds, United Kingdom, LS13EX