Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study) (NCT03884790) | Clinical Trial Compass
TerminatedNot Applicable
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Stopped: The enrolment phase was halted prematurely due to logistic issues ( SARS-CoV2 pandemic). All patients enrolled completed the follow-up visits according to the study protocol.
Bosnia and Herzegovina, Israel, Italy16 participantsStarted 2019-01-22
Plain-language summary
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects up to 6 cm using GreenBone Implant. After the surgery, the Patients will be monitored at pre-scheduled visits up to 12 months. Adverse events, pain, quality of life and functional parameters, as well as X-ray and CT scan, will be evaluated at scheduled follow-up visits. An independent Data Safety Monitoring Board (DSMB) will review the safety reports at regular intervals and Serious Adverse Events (SAE) as soon as reported, to protect Patients participating in the study. The initial phase of the study contemplates the treatment of bone defects up to 3 cm. An adaptive interim analysis will be performed when the first 7 Patients will have completed the 6-month follow-up visit. The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety), and provide one of the following recommendations to the Sponsor: a) to stop the study for unacceptable frequency and severity of adverse events or b) to continue the study up to 25 Patients recruited and to include at least 5 Patients with a longer bone defect (\> 3 cm up to 6 cm).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female Patients.
✓. Patients aged ≥ 18 and ≤ 65 years old.
✓. Patients requiring long bone defect reconstructions up to 3 cm, resulting from high-energy traumatic events, or from the treatment of complex bone non-unions in the extremities (arms and legs), or patients undergoing the second stage of the Masquelet technique.
✓. Patients understanding the nature of the study and providing their informed consent to participation.
✓. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.
Exclusion criteria
✕. Patients with bone infection 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 enrolment.
✕. Patients with concomitant infectious systemic diseases at the time of enrolment.