Pre-market Study to Evaluate Safety and Performance of GreenBone Implant

NCT03836404 | Completed DMC

• 1 other identifier: GB-01-18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site. The other remaining patients will be enrolled in the three sites only after positive evaluation of the 3 months Follow Up (FU) interim report analysis by Data Safety Monitoring Board (DSMB). The Patients enrolled in this clinical investigation will undergo a scheduled surgery aiming to reconstruct iliac crest bone defect using GreenBone Implant. After surgery, the Patients will be monitored at pre-scheduled visits up to 6 months. The FU will be extended at 12 months only in case of no complete healing and/or in case of no resolved SAE at the 6 months FU visit. Adverse events, pain, quality of life and X-ray will be evaluated at scheduled follow-up visits. An independent 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. As specified before, an adaptive interim analysis will be performed when at least 5 Patients will have completed the 3 month follow up visit, (V5). The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety) in order to continue the study up to 15 Patients.

Conditions

Bone Substitutes

Keywords

Bone substitute; Bone regeneration

Outcome Measures

Primary Outcomes (1)

• Safety Evaluation assessed by Evaluation of adverse events rate

  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 Outcomes (6)

• Device Implant Technical Success

  At the end of surgical procedure (visit 2, 1 day)

• Bone regeneration evaluation

  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

  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

  between 1 and 6 months

• Treatment tolerability

  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)

Study Arms (1)

Iliac Crest reconstruction surgery

EXPERIMENTAL

The patients in the study group will be surgically treated and the GreenBone bone substitute will be implanted

Device: Iliac crest reconstruction surgery

Interventions

Iliac crest reconstruction surgery DEVICE

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.

Iliac Crest reconstruction surgery

Eligibility Criteria

• Age: 18 Years - 70 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 ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GreenBone Ortho S.p.A.: lead

Study Sites (1)

Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary

Leeds, LS13EX, United Kingdom

Location

Study Officials

• Peter Giannoudis, MD

  Leeds Teaching Hospital NHS

  PRINCIPAL INVESTIGATOR

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: February 7, 2019
• First Posted: February 11, 2019
• Study Start: March 6, 2019
• Primary Completion: April 29, 2022
• Study Completion: December 19, 2022
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

GB (1)