NCT03884790

Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)

Terminated NA Results posted Last updated 10 April 2025

What this trial tests

NA trial testing surgical repair of long bone defects in Bone Substitutes in 16 participants. Terminated before completion.

Timeline

22 January 2019

Primary endpoint
8 June 2023

8 June 2023

Quick facts

Lead sponsor	GreenBone Ortho S.p.A.
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	16
Start date	22 January 2019
Primary completion	8 June 2023
Estimated completion	8 June 2023
Sites	8 locations across Bosnia and Herzegovina, Italy, Serbia, United Kingdom, Israel, Slovenia

Drugs / interventions tested

• surgical repair of long bone defects

Conditions studied

• Bone Substitutes — all drugs for Bone Substitutes →
• Bone Defect — all drugs for Bone Defect →

Sponsor

GreenBone Ortho S.p.A.

Who can join

Adults 18 to 65, any sex, with Bone Substitutes or Bone Defect. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · Overall study period up to 12 months

Evaluation of adverse events rate during the study period.

Group	Value	95% CI
Surgical Repair of Long Bone Defects	16

Bone Union (Bone Healing) Evaluation Through Modified Lane and Sandhu Radiological Scoring System Secondary · At the end of visits 1,3,4,5,6,7,8 (respectively performed at screening and 1,2,3,6,9,12 months after the surgery, each visit is 1 day)

Evaluation of the bone regeneration in the area of intervention in comparison to baseline (V1), by means of X-ray and/or CT scan examination, on visits V3, V4, V5, V6, V7 and V8. X-ray scoring systems have been implemented according to the criteria proposed by modified Lane and Sandhu Radiological Scoring System (Lane 1987). This scoring system evaluates bone formation and union. To evaluate the bone formation, there is a scale with 5 points, from 0 to 4 (0=No evidence of bone formation-4=Bone formation occupying 100% of defect). To evaluate bone union, there is a scale with 3 points, from 0 t

Group	Value	95% CI
Surgical Repair of Long Bone Defects	7
Surgical Repair of Long Bone Defects	3
Surgical Repair of Long Bone Defects	1

Bone Regeneration Evaluation Through Modified Lane and Sandhu Radiological Scoring System Secondary · At the end of visits 1,3,4,5,6,7,8 (respectively performed at screening and 1,2,3,6,9,12 months after the surgery, each visit is 1 day)

Evaluation of the bone regeneration in the area of intervention in comparison to baseline (V1), by means of X-ray and/or CT scan examination, on visits V3, V4, V5, V6, V7 and V8. X-ray scoring systems have been implemented according to the criteria proposed by modified Lane and Sandhu Radiological Scoring System (Lane 1987). This scoring system evaluates bone formation and union. To evaluate the bone formation, there is a scale with 5 points, from 0 to 4 (0=No evidence of bone formation-4=Bone formation occupying 100% of defect). To evaluate bone union, there is a scale with 3 points, from 0 t

Bone formation occupying 100% of defect

Group	Value	95% CI
Surgical Repair of Long Bone Defects	4

Bone formation occupying 75% of defect

Group	Value	95% CI
Surgical Repair of Long Bone Defects	3

Bone formation occupying 50% of defect

Group	Value	95% CI
Surgical Repair of Long Bone Defects	4

Evaluation of Pain Secondary · At the end of visits 1,3,4,5,6,7,8 (respectively performed at screening and 1,2,3,6,9,12 months after the surgery, each visit is 1 day)

Evaluation of degree of pain perceived by the Patient, by means of a Visual Analogue Score (VAS/0-10 point scale), on visits V1, V3, V4, V5, V6, V7 and V8. The Visual Analogue Score (VAS) that a scale with 10 points, from 0 to 10, 0 indicates "no pain at all" and 10 the "worst pain ever".

VAS score - visit 1

Group	Value	95% CI
Surgical Repair of Long Bone Defects	5.38	± 2.25

VAS score - visit 3

Group	Value	95% CI
Surgical Repair of Long Bone Defects	3.47	± 1.85

VAS score - visit 4

Group	Value	95% CI
Surgical Repair of Long Bone Defects	2.92	± 1.61

VAS score - visit 5

Group	Value	95% CI
Surgical Repair of Long Bone Defects	3.29	± 1.33

VAS score - visit 6

Group	Value	95% CI
Surgical Repair of Long Bone Defects	2.46	± 1.71

VAS score - visit 7

Group	Value	95% CI
Surgical Repair of Long Bone Defects	2.8	± 2.15

VAS score - visit 8

Group	Value	95% CI
Surgical Repair of Long Bone Defects	2.27	± 2.28

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Surgical Repair of Long Bone Defects

Serious: 8/16 (50%)

Deaths: 0/16

Serious adverse events (5 terms)

Reaction	System	Surgical Repair of Long Bo…
Fixation system breakage	Surgical and medical procedures	—
Fracture non-union	Surgical and medical procedures	—
Open reduction with external fixation	Surgical and medical procedures	—
Pseudarthrosis	Surgical and medical procedures	—
Muscle abscess	Skin and subcutaneous tissue disorders	—

Other adverse events (12 terms — click to expand)

Reaction	System	Surgical Repair of Long Bo…
Pain in leg or arm	Musculoskeletal and connective tissue disorders	—
Allergic Reaction	Musculoskeletal and connective tissue disorders	—
External fixator loosening	Surgical and medical procedures	—
Wound dehiscence	Musculoskeletal and connective tissue disorders	—
Itching	Musculoskeletal and connective tissue disorders	—
Occasional serous drainage	Musculoskeletal and connective tissue disorders	—
Joint instability	Musculoskeletal and connective tissue disorders	—
Artery rupture	Injury, poisoning and procedural complications	—
Constipation	Gastrointestinal disorders	—
Presbyopia	Eye disorders	—
Rectal pain	Eye disorders	—
Skin necrosis	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Fixation system breakage, Fracture non-union, Open reduction with external fixation, Pseudarthrosis, Muscle abscess.

Data from ClinicalTrials.gov NCT03884790 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Application of Bone Marrow Mesenchymal Stem/Stromal Cells to Repair Skeletal Tissue.
   Arthur A, Gronthos S. · · 2020 · cited 174× · PMID 33371306 · DOI 10.3390/ijms21249759
2. Scaffold Guided Bone Regeneration for the Treatment of Large Segmental Defects in Long Bones.
   Schulze F, Lang A, Schoon J, Wassilew GI, et al · · 2023 · cited 31× · PMID 36830862 · DOI 10.3390/biomedicines11020325