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

NCT03884790 | Terminated Results DMC

• 1 other identifier: GB-02-18
• Study Type: interventional
• Target: 16
• Locations: 6 countries
• Sites: 8

Brief Summary

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).

Conditions

Bone Substitutes; Bone Defect

Keywords

Bone substitute; Bone regeneration

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Evaluation of adverse events rate during the study period.

  Overall study period up to 12 months

Secondary Outcomes (6)

• Bone Union (Bone Healing) Evaluation Through Modified Lane and Sandhu Radiological Scoring System

  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)

• Bone Regeneration Evaluation Through Modified Lane and Sandhu Radiological Scoring System

  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 Pain

  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

  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)

• Global Tolerability of Patient to Treatment

  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)

Study Arms (1)

Surgical repair of long bone defects

EXPERIMENTAL

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

Interventions

surgical repair of long bone defects DEVICE

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.

Surgical repair of long bone defects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female Patients.
• Patients aged ≥ 18 and ≤ 65 years old.
• Patients requiring long bone defect reconstructions up to 3 cm, resulting from high-energy traumatic events, or from the treatment of complex bone non-unions in the extremities (arms and legs), or patients undergoing the second stage of the Masquelet technique.
• Patients understanding the nature of the study and providing their informed consent to participation.
• Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.

You may not qualify if:

• Patients with bone infection 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 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, excluding steroids.
• Patients with active autoimmune disease.
• Patients with a pre-existing calcium metabolism disorder (i.e. hypercalcemia).
• Known hyperthyroidism or autonomous thyroid adenoma.
• Patients with coagulopathy or bleeding disorders.
• Patients who are not allowed to undergo the study procedures involving imaging (X-rays, CT scan) based on Investigator's judgement.
• 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.
• Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.

Sponsors & Collaborators

• GreenBone Ortho S.p.A.: lead

Study Sites (8)

Orthopedic and Traumatology Clinic, University Clinical Center of Republic of Srpska

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

Orthopedic Surgery Section, Division of Surgery,Rambam Health Care Campus

Haifa, 3109601, Israel

Location

UOC di Ortopedia e Traumatologia - Ospedali Civili di Brescia

Brescia, Lombardy, 25123, Italy

Location

Unitá Operativa di Traumatologia,Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

U.O.C. Ortopedia e Traumatologia - Osp. Maggiore "C.A. Pizzardi"

Bologna, 40133, Italy

Location

Orthopedic Surgery Section, Global Care Surgery Hospital

Novi Sad, 21000, Serbia

Location

Clinical Department for Traumatology,University Medical Center of Ljubljana

Ljubljana, SI-1000, Slovenia

Location

Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary

Leeds, LS13EX, United Kingdom

Location

Results Point of Contact

• Title: Senior Clinical Affairs Manager
• Organization: GreenBone Ortho SpA

sonia.granados@greenbone.it

+393479747691

Study Officials

• Peter Giannoudis, MD

  Leeds Teaching Hospital NHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: January 22, 2019
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2024-06

Locations

GB (1); SL (1); IL (1); SE (1); BO (1); IT (3)