NCT03836404: GreenBric

Pre-market Study to Evaluate Safety and Performance of GreenBone Implant

Completed NA Last updated 7 June 2024

What this trial tests

NA trial testing Iliac crest reconstruction surgery in Bone Substitutes in 15 participants. Completed in 19 December 2022.

Timeline

6 March 2019

Primary endpoint
29 April 2022

19 December 2022

Quick facts

Lead sponsor	GreenBone Ortho S.p.A.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	15
Start date	6 March 2019
Primary completion	29 April 2022
Estimated completion	19 December 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Iliac crest reconstruction surgery

Conditions studied

• Bone Substitutes — all drugs for Bone Substitutes →

Sponsor

GreenBone Ortho S.p.A.

Who can join

Adults 18 to 70, any sex, with Bone Substitutes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 will be enrolled in the three sites only after positive evaluation of the 3 months Follow Up (FU) interim report analysis by Data Safety Monitoring Board (DSMB). The Patients enrolled in this clinical investigation will undergo a scheduled surgery aiming to reconstruct iliac crest bone defect using GreenBone Implant. After surgery, the Patients will be monitored at pre-scheduled visits up to 6 months. The FU will be extended at 12 months only in case of no complete healing and/or in case of no resolved SAE at the 6 months FU visit. Adverse events, pain, quality of life and X-ray will be evaluated at scheduled follow-up visits. An independent 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. As specified before, an adaptive interim analysis will be performed when at least 5 Patients will have completed the 3 month follow up visit, (V5). The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety) in order to continue the study up to 15 Patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and performance of a novel synthetic biomimetic scaffold for iliac crest defect reconstruction during surgical treatment of pelvic girdle pain: a first-in-human trial.
   Giannoudis PV, Andrzejwski P, Chloros G, Hensor EMA. · · 2025 · cited 1× · PMID 39821211 · DOI 10.1093/bmb/ldae023