Trial Outcomes & Findings for Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study) (NCT NCT03884790)
NCT ID: NCT03884790
Last Updated: 2025-04-10
Results Overview
Evaluation of adverse events rate during the study period.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Overall study period up to 12 months
Results posted on
2025-04-10
Participant Flow
Enrollment phase started in January 2019
Participant milestones
| Measure |
Surgical Repair of Long Bone Defects
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
surgical repair of long bone defects: Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only patients treated for bone defect repair were included in the analysis population (16 participants)
Baseline characteristics by cohort
| Measure |
Surgical Repair of Long Bone Defects
n=16 Participants
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
surgical repair of long bone defects: Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Age, Categorical
Between 18 and 65 years
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15 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Age, Categorical
>=65 years
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1 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Sex: Female, Male
Female
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4 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Sex: Female, Male
Male
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12 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Race (NIH/OMB)
Black or African American
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1 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Race (NIH/OMB)
White
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15 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Region of Enrollment
Italy
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9 participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Region of Enrollment
United Kingdom
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1 participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Region of Enrollment
Israel
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1 participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Region of Enrollment
Serbia
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4 participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Region of Enrollment
Bosnia and Herzegovina
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1 participants
n=99 Participants • Only patients treated for bone defect repair were included in the analysis population (16 participants)
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Bone defect dimension
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2.3 cm
STANDARD_DEVIATION 1.4 • n=99 Participants
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PRIMARY outcome
Timeframe: Overall study period up to 12 monthsEvaluation of adverse events rate during the study period.
Outcome measures
| Measure |
Surgical Repair of Long Bone Defects
n=16 Participants
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
surgical repair of long bone defects: Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.
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Number of Participants With Adverse Events
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16 Participants
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SECONDARY outcome
Timeframe: 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)Population: Patients that achieved the complete follow-up up to 12 months (11 out of the 16 patients)
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 to 2 (0=Non-union-2=Radiographic union).
Outcome measures
| Measure |
Surgical Repair of Long Bone Defects
n=11 Participants
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
surgical repair of long bone defects: Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.
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Bone Union (Bone Healing) Evaluation Through Modified Lane and Sandhu Radiological Scoring System
Bone union (Bone healing)
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7 Participants
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Bone Union (Bone Healing) Evaluation Through Modified Lane and Sandhu Radiological Scoring System
Possible bone union (Possible healing)
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3 Participants
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Bone Union (Bone Healing) Evaluation Through Modified Lane and Sandhu Radiological Scoring System
Not union (not healing)
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1 Participants
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SECONDARY outcome
Timeframe: 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)Population: Patients that achieved the complete follow-up up to 12 months (11 out of the 16 patients)
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 to 2 (0=Non-union-2=Radiographic union).
Outcome measures
| Measure |
Surgical Repair of Long Bone Defects
n=11 Participants
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
surgical repair of long bone defects: Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.
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Bone Regeneration Evaluation Through Modified Lane and Sandhu Radiological Scoring System
Bone formation occupying 100% of defect
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4 Participants
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Bone Regeneration Evaluation Through Modified Lane and Sandhu Radiological Scoring System
Bone formation occupying 75% of defect
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3 Participants
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Bone Regeneration Evaluation Through Modified Lane and Sandhu Radiological Scoring System
Bone formation occupying 50% of defect
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4 Participants
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SECONDARY outcome
Timeframe: 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)Population: Patients surgically treated with GreenBone Bone Substitute and that completed all follow-up visits
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".
Outcome measures
| Measure |
Surgical Repair of Long Bone Defects
n=16 Participants
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
surgical repair of long bone defects: Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.
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Evaluation of Pain
VAS score - visit 1
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5.38 score on a scale
Standard Deviation 2.25
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Evaluation of Pain
VAS score - visit 3
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3.47 score on a scale
Standard Deviation 1.85
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Evaluation of Pain
VAS score - visit 4
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2.92 score on a scale
Standard Deviation 1.61
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Evaluation of Pain
VAS score - visit 5
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3.29 score on a scale
Standard Deviation 1.33
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Evaluation of Pain
VAS score - visit 6
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2.46 score on a scale
Standard Deviation 1.71
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Evaluation of Pain
VAS score - visit 7
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2.8 score on a scale
Standard Deviation 2.15
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Evaluation of Pain
VAS score - visit 8
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2.27 score on a scale
Standard Deviation 2.28
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SECONDARY outcome
Timeframe: 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 Quality-of-Life by means of EuroQoL EQ-5D-5L Validated Questionnaire, on visits V1, V3, V4, V5, V6, V7 and V8. The EQ-5D-5L is a descriptive system. This system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of visits 3,4,5,6,7,8 (respectively performed 1,2,3,6,9,12 months after the surgery, each visit is 1 day)Evaluation of global tolerability to treatment of Patient (by the Investigator), through a standardized questionnaire, on visits V3, V4, V5, V6, V7 and V8. Global Tolerability Questionnaire is a questionnaire with 6 questions that are completed by the investigator in order to evaluate the operated site.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: between 1 and 12 monthsEvaluation of the number of re-interventions occurring for the Patient throughout the 12-month observation period.
Outcome measures
Outcome data not reported
Adverse Events
Surgical Repair of Long Bone Defects
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Surgical Repair of Long Bone Defects
n=16 participants at risk
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
surgical repair of long bone defects: Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.
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Surgical and medical procedures
Fixation system breakage
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31.2%
5/16 • Number of events 5 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Surgical and medical procedures
Fracture non-union
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Surgical and medical procedures
Open reduction with external fixation
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Surgical and medical procedures
Pseudarthrosis
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Skin and subcutaneous tissue disorders
Muscle abscess
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Other adverse events
| Measure |
Surgical Repair of Long Bone Defects
n=16 participants at risk
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
surgical repair of long bone defects: Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.
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Musculoskeletal and connective tissue disorders
Allergic Reaction
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Surgical and medical procedures
External fixator loosening
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Musculoskeletal and connective tissue disorders
Wound dehiscence
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Musculoskeletal and connective tissue disorders
Itching
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Musculoskeletal and connective tissue disorders
Occasional serous drainage
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Musculoskeletal and connective tissue disorders
Pain in leg or arm
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18.8%
3/16 • Number of events 7 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Musculoskeletal and connective tissue disorders
Joint instability
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Injury, poisoning and procedural complications
Artery rupture
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Gastrointestinal disorders
Constipation
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6.2%
1/16 • Number of events 2 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Eye disorders
Presbyopia
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Eye disorders
Rectal pain
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Skin and subcutaneous tissue disorders
Skin necrosis
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6.2%
1/16 • Number of events 1 • 1 year
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place