Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
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|ClinicalTrials.gov Identifier: NCT03884790|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bone Substitutes Bone Defect||Device: surgical repair of long bone defects||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pre-market, Multi-center, International, Open-label, Single-arm Study to Evaluate the Safety and Performance of a Class III Medical Device (GreenBone Implant) for Surgical Repair of Long Bone Defects|
|Actual Study Start Date :||January 22, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Surgical repair of long bone defects
The Patients in the study group will be surgically treated and the GreenBone Bone Substitute will be implanted
Device: 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.
- Safety Evaluation assessed by Evaluation of adverse events rate [ Time Frame: Overall study period up to 12 months ]Evaluation of adverse events rate during the study period. All adverse occurrences (serious/non-serious or device-related/non device-related) will be recorded prospectively, categorized and evaluated for causality using defined criteria.
- Technical Success of surgical procedure [ Time Frame: During of surgical procedure (visit 2, 1 day) ]
Evaluation of technical success, defined as successful delivery of the GreenBone Implant in the target defect bone evaluated at V2 (during surgical procedure).
Technical success regards the surgical procedure and evaluates the performance of medical device.
- Bone regeneration evaluation through modified Lane and Sandhu Radiological Scoring System (bone formation, union and remodeling) [ Time Frame: 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, union and remodeling. 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 and remodelling, there is a scale with 3 points, from 0 to 2 (0=Non-union-2=Radiographic union).
- Functional assessment [ Time Frame: 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) ]
Functional Assessment: evaluation of functional recovery of Patient, by means of a standardized questionnaire (36-Item Short Form Survey - SF-36), on visits V1, V3, V4, V5, V6, V7 and V8. The questionnaire is Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36). The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower score=more disability, higher scores=less disability.
- Physical functioning
- Bodily pain
- General health perceptions
- Physical role functioning
- Emotional role functioning
- Social role functioning
- Mental health
- Evaluation of pain [ Time Frame: 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".
- Evaluation of Quality-of-Life [ Time Frame: 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.
- Global Tolerability of patient to treatment [ Time Frame: 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.
- Reinterventions number [ Time Frame: between 1 and 12 months ]Evaluation of the number of re-interventions occurring for the Patient throughout the 12-month observation period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884790
|Contact: Lorenzo Pradella, PHD||+39 firstname.lastname@example.org|
|Contact: Elena Venturelli, Graduated||+39 email@example.com|
|Bosnia and Herzegovina|
|Orthopedic and Traumatology Clinic, University Clinical Center of Republic of Srpska||Not yet recruiting|
|Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000|
|Orthopedic Surgery Section, Division of Surgery,Rambam Health Care Campus||Recruiting|
|Haifa, Israel, 3109601|
|Unitá Operativa di Traumatologia,Humanitas Research Hospital||Recruiting|
|Rozzano, Milano, Italy, 20089|
|Orthopedic Surgery Section, Global Care Surgery Hospital||Not yet recruiting|
|Novi Sad, Serbia, 21000|
|Clinical Department for Traumatology,University Medical Center of Ljubljana||Not yet recruiting|
|Ljubljana, Slovenia, SI-1000|
|Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary||Not yet recruiting|
|Leeds, United Kingdom, LS13EX|
|Principal Investigator:||Peter Giannoudis, MD||Leeds Teaching Hospital NHS|