- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03836404
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (GreenBric)
Pre-market, Multi-center, National, Open-label, Single-arm Study to Evaluate the Safety and Performance of a Class III Medical Device (GreenBone Implant) for Iliac Crest Reconstruction Following Bone Graft Harvesting for Pelvic Fusion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a pre-market multi-centre, national, open label, single-arm, study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for iliac crest reconstruction following bone graft harvesting for pelvic fusion. During pelvic fusion a considerable part of the iliac crest is removed and it is used as autologous bone graft for the fusion of the pubis symphysis. The bone defect that is formed in the iliac crest is usually filled with bone obtained from the cows (bovine xenograft) and or human donors (allograft). This carries the risk of transferring disease from animals and/or humans to the patient; there is also a risk of host local allergic reaction. Bone substitutes are devoid of the above risks and therefore they could be used alternatively to xenografts and allografts.
GreenBone is a ceramic resorbable bone scaffold that has very similar structure to bone. It can be produced in large quantities, shaped easily and sterilised without losing its properties. Consequently, it is an ideal substitute that could be used to fill bone defects. This study will assess the safety of using GreenBone to reconstruct iliac crest defects. Moreover it will assess its capacity of promoting new bone formation. The investigators will recruit 15 patients who will undergo pelvic fusion and instead of bovine xenograft the investigators will use the GreenBone implant for the iliac crest reconstruction.
Patients will be followed up for 6 months in total. Safety will be evaluated by monitoring local and potential systemic reactions; its bone forming capacity will also be assessed by its integration into the iliac crest.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: LORENZO PRADELLA, PHD
- Phone Number: +39 0546 46666
- Email: lorenzo.pradella@greenbone.it
Study Contact Backup
- Name: ELENA VENTURELLI, Graduated
- Phone Number: +39 0546 46666
- Email: elena.venturelli@greenbone.it
Study Locations
-
-
-
Leeds, United Kingdom, LS13EX
- Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female Patients.
- Patients aged ≥ 18 and ≤ 70 years old.
- Patients requiring iliac crest reconstruction secondary to pelvic fusion.
- Patients understanding the nature of the study and providing their informed consent to participation.
- Patients willing and able to attend the visits and procedures foreseen by study protocol.
Exclusion Criteria:
- Patients with bone infections 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 study enrolment.
- Patients with concomitant infectious systemic diseases at the time of enrolment.
- Patients with known inflammatory systemic diseases at the time of enrolment.
- Patients with concomitant myeloproliferative disorders at the time of enrolment.
- Patients currently treated with systemic immunosuppressive agents, including steroids.
- Patients with active autoimmune disease.
- Patients with coagulopathy or bleeding disorders.
- Patients who have received a previous treatment of bone substitution in the same anatomical site.
- Patients with known or suspected allergy or hypersensitivity to the GreenBone Implant components.
Patients who are participating or have participated in any other conflicting studies within the 30 days before the study enrolment. (This does not include patients who have taken part in other non-conflicting non-interventional or observational studies.
These patients may still be eligible).
- Pregnant women and/or women that intend to be pregnant within 6 or 12 months from surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Iliac Crest reconstruction surgery
The patients in the study group will be surgically treated and the GreenBone bone substitute will be implanted
|
When autologous bone graft is needed for the treatment of non-unions or bone defects, is harvested from the pelvic iliac crest.
Harvested tricortical graft blocks are used to facilitate fusion of joints (ie pubis symphysis, sacroiliac joint), to structurally support metaphyseal areas of articular impaction injuries and to fill in metaphyseal bone voids.
The GreenBone device, with its inherent physical and biomimic properties, possesses similar structural properties to bone, thus, being the ideal material to be used for the treatment of the bone defect (3- 4cm) induced from the harvested tricortical iliac crest, restoring therefore the pelvic anatomy and minimising the risk of chronic pain, haematoma formation and herniation of the abdominal contents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Evaluation assessed by Evaluation of adverse events rate
Time Frame: Overall study period up to 6 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.
|
Overall study period up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Implant Technical Success
Time Frame: At the end of surgical procedure (visit 2, 1 day)
|
Technical Success, defined as successful delivery of the bone substitute in the target defect bone evaluated at V2 (at surgical procedure);
|
At the end of surgical procedure (visit 2, 1 day)
|
Bone regeneration evaluation
Time Frame: At the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
|
Evaluation of the bone regeneration in the area of intervention, by means of X-ray and/or CT examination by a radiologist, on visit V3, V4, V5, V6, V7; X-ray scoring systems have been implemented according to the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) (Lane 1987)
|
At the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
|
Quality of Life evaluation
Time Frame: At screening visit (V1) and at the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
|
Evaluation of Quality of Life by means of a validated EuroQol questionnaire administered at every visit from V1 to V6/V7 (excluding visit 2) (Price 1983)
|
At screening visit (V1) and at the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
|
Evaluation of Pain
Time Frame: between 1 and 6 months
|
Evaluation of degree of pain perceived by the Patient, by means of a 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"
|
between 1 and 6 months
|
Treatment tolerability
Time Frame: At the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
|
Evaluation of global tolerability to treatment of Patient (by the Investigator), through a standardized EuroQol questionnaire, on every visit from V3 to V6/V7
|
At the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
|
Reinterventions number
Time Frame: between 1 and 6 months
|
Evaluation of the number of re-interventions occurring for the Patient throughout the .
6 months observation period.
|
between 1 and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Giannoudis, MD, Leeds Teaching Hospital NHS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GB-01-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bone Substitutes
-
Turku University HospitalUniversity of TurkuUnknown
-
Bahçeşehir UniversityOndokuz Mayıs UniversityCompletedBone Regeneration | Bone Substitutes | Bone And Bones
-
GreenBone Ortho S.p.A.TerminatedBone Substitutes | Bone DefectBosnia and Herzegovina, Israel, Italy, Serbia, Slovenia, United Kingdom
-
University of Nove de JulhoRecruitingBone Substitutes | Extracting Own TeethBrazil
-
University of Nove de JulhoCompletedBone Substitutes | Extracting Own TeethBrazil
-
Universidad Científica del SurNYU Langone HealthCompletedDental Implants | Bone Regeneration | Cone-beam Computed Tomography | Bone Substitutes | Bone TransplantationPeru
-
Medical University of GrazDentsply Sirona ImplantsCompletedSinus Floor Augmentation | Bone Substitutes | Hydroxyapatite | Calcium Phosphates | Rhodophyta
-
Maco Productions S.A.S.SynteractHCRCompletedAdverse Effects in the Therapeutic Use of Plasma SubstitutesUnited Kingdom, Belgium, Greece, Spain
-
OctapharmaCompletedAdverse Effects in the Therapeutic Use of Plasma SubstitutesUnited States
-
University of Roma La SapienzaCompletedAtrophy | Jaw, Edentulous, Partially | Sinus Floor Augmentation | Bone Regeneration | Bone Substitutes
Clinical Trials on Iliac crest reconstruction surgery
-
Tehran University of Medical SciencesCompletedGenovarumIran, Islamic Republic of
-
Banc de Sang i TeixitsHospital ASEPEYO Sant CugatCompletedAtrophic Nonunion of FractureSpain
-
Second Affiliated Hospital, School of Medicine,...West China Hospital; Tongji Hospital; Werner Wicker KlinikRecruiting
-
Shahid Beheshti University of Medical SciencesCompletedCleft of Alveolar RidgeIran, Islamic Republic of
-
OrthoCarolina Research Institute, Inc.Stryker Trauma GmbHWithdrawnAdult Acquired FlatfootUnited States
-
Technical University of MunichCompletedFracture, Healed, Fibrous Union
-
BioAlpha Inc.Unknown
-
Hebei Medical University Third HospitalCompletedDepressed Tibial Plateau FracturesChina
-
Rothman Institute OrthopaedicsEnrolling by invitation
-
Indonesia UniversityUnknownHealing of FractureIndonesia