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GreenBRIC Clinical Trial (GreenBRIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541343
Recruitment Status : Unknown
Verified May 2018 by PeterGiannoudis, University of Leeds.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
University of Leeds
Information provided by (Responsible Party):
PeterGiannoudis, University of Leeds

Study Description
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Brief Summary:

This is a multi-centre, prospective, open-label, single-arm, first-in-man clinical investigation. The patients enrolled in this clinical trial will undergo elective surgery for pelvic fusion. Following harvesting of autologous bone graft form the iliac crest, the donor site will be reconstructed with a new scaffold known as GreenBone.

GreenBone is a ceramic reabsorbable scaffold which is obtained by the transformation of wood. It has a very similar structure to bone.

The aim of the study is to evaluate the safety of using the GreenBone in humans and also to evaluate its capacity to promote new bone formation at the donor site.


Condition or disease Intervention/treatment Phase
Pelvic Girdle Pain Device: GreenBone implant Not Applicable

Detailed Description:

Bone defects can result from high-energy traumatic events, bone resection due to different pathologies such as tumors or infection, or from the treatment of complex non-unions, all very challenging conditions in orthopaedic practice. Defects of pelvic iliac crest most frequently result from harvesting of iliac bone graft for bone grafting and fusion procedures and can be associated with significant morbidity.

Current reconstruction options of the bone defects usually imply the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favouring the migration of cells from the neighbouring tissues to fill the gap. Autografts and allografts are the most commonly used bone grafts currently used for large bone defects. However, the use of both types of grafts has significant disadvantages. For iliac crest reconstruction in particular, different types of synthetic materials and xenografts have been used. However, at the moment, there is not any ideal bone substitute with the necessary osteoinductive, osteoconductive and mechanical properties. GreenBone is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects.

When autologous bone graft is needed for the treatment of non-unions or bone defects, it is harvested from the pelvic iliac crest in the form of either tricortical graft material or cancellous bone. Harvested tricortical graft blocks are used to facilitate fusion of joints (i.e. pubis symphysis, sacroiliac joint), to structurally support metaphyseal areas of articular impaction injuries (i.e. tibial plateau) and to fill in metaphyseal bone voids. The GreenBone device, with its inherent physical and biomimetic properties, possesses similar structural properties to bone, and thus, it can be considered the ideal bone graft. Reconstruction of the donor site restores the pelvic anatomy and minimises the risk of chronic pain, haematoma formation and herniation of the abdominal contents.

The purpose of this study is to assess the safety of the use of GreenBone in patients undergoing iliac crest reconstruction to restore bone defects. In particular, this study will evaluate the progression of bone healing and regeneration of the donor site throughout a 6-month observation period, it will evaluate the postoperative pain related to iliac crest graft harvesting, and it will evaluate the health related quality of life of patients at 6 months.

Patient who will be enrolled in the study will receive exactly the same operation that they would receive normally for pelvic fusion with the only difference that instead of having xenograft (bone obtained from cows) applied to the donor site (the site in your pelvis from where the surgeon will harvest the bone graft), you will receive the GreenBone material.

Following surgery patients will be followed-up for 6 months. At each follow-up visit, the safety of the use of the GreenBone implant will be assessed and patients will complete a pain-scale and quality of life questionnaires. Moreover, incorporation of the Bone graft into the iliac crest will be assessed radiologically.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pre-Market Multicenter 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.
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: GreenBone
All patients will receive the GreenBone implant instead of bovine xenograft.
 Device: GreenBone implant
Patients will receive the GreenBone implant instead of bovine xenograft for iliac crest reconstruction following autologous bone graft harvesting.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of safety of the use of GreenBone implant in humans. [ Time Frame: 6 months. ]
    Evaluation of adverse events 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.


Secondary Outcome Measures :
  1. Progression of healing at 6 months. [ Time Frame: 1 month, 2 months, 3 months, 6 months. ]
    Evaluation of the bone regeneration in the area of intervention, by means of X-ray examination by an independent radiologist; X-ray scoring systems have been implemented according to the criteria proposed by Lane and Sandhu (bone formation, union and remodelling). Score 0 indicates no signs of healing while max score 10 indicates complete healing/incorporation of the graft.

  2. Change of pain at 6 months. [ Time Frame: 1 month, 2 months, 3 months, 6 months. ]
    Evaluation of degree of pain perceived by the patient, by means of a VAS (Visual Analogue Scale) (0-100 mm), on every visit.

  3. Change in Quality of life at 6 months. [ Time Frame: 1 month, 2 months, 3 months, 6 months. ]
    Evaluation of Quality of Life by means of a validated EuroQol (EQ-5D) questionnaire administered at every follow-up visit.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients requiring iliac crest reconstruction secondary to pelvic fusion
  • Patients understanding the nature of the study and providing their informed consent to participation
  • Patient is considered able to complete the study assessment and visit schedule in the opinion of the investigating team.

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 other clinical studies within the 30 days before the study enrolment.
  • Pregnant women and/or women that intend to be pregnant within 6 months from surgery.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541343


Contacts
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Contact: Peter Giannoudis, MD, FRCS 01133922750 peter.giannoudis@nhs.net

Locations
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United Kingdom
James Cook university Hospital
Middlesbrough, Teesside, United Kingdom, TS4 3BW
Contact: Andrew Gray, MD, FRCS    07813 799735    andrew.gray1@nhs.net   
Principal Investigator: Andrew Gray, MD FRCS         
University Hospsital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Khitish Mohanty, MBBS FRCS    02920745049    khitishmohanty@hotmail.com   
Principal Investigator: Khitish Mohanty, MBBS, FRCS         
Leeds Teaching Hospitals
Leeds, Yorkshire, United Kingdom, LS1 3EX
Contact: Peter Giannoudis, MD,FRCS    01133922750    peter.giannoudis@nhs.net   
Principal Investigator: Peter Giannoudis, MD, FRCS         
Sponsors and Collaborators
PeterGiannoudis
University of Leeds
Investigators
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Principal Investigator: Peter Giannoudis, MD, FRCS University of Leeds
More Information
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Responsible Party: PeterGiannoudis, Professor, University of Leeds
ClinicalTrials.gov Identifier: NCT03541343    
Other Study ID Numbers: 246763
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pelvic Girdle Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Pelvic Pain