Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease

NCT05971329 | Recruiting DMC

• 1 other identifier: ZG-2022-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function. Participants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function.

Conditions

Radiculopathy, Cervical; Myelopathy Cervical; Neurological Abnormality; Disc Disease; Disc Degeneration

Outcome Measures

Primary Outcomes (1)

• Subjects with Radiologic Determination of Bone Fusion of the Treated Cervical Vertebral Bones

  Radiological Fusion of the cervical vertebral bones, assessed using planar X-radiographs or computed tomography. Fusion is defined as continuous bridging bone between the endplates of the operated cervical vertebral bones. Subjects with fusion will be assessed as having a successful outcome while subjects without fusion will have failed the procedure.

  1 year post surgery

Secondary Outcomes (1)

• Quality of Life via Short Form (SF12v2) Health Survey

  1 year post surgery

Study Arms (1)

Pilot Study of ZetaFuse Bone Graft for the Treatment of Cervical Degenerative Disc Disease

EXPERIMENTAL

Involves the use of a medical device. The prepared ZetaFuse Bone Graft is packed into the hollow space of a PEEK interbody before surgical implantation.

Device: Cervical Fusion (ZetaFuse™ Bone Graft)

Interventions

Cervical Fusion (ZetaFuse™ Bone Graft) DEVICE

Fusion of the C3-C7 cervical vertebral bodies

Pilot Study of ZetaFuse Bone Graft for the Treatment of Cervical Degenerative Disc Disease

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 to 75 years (inclusive) at the time of enrollment.
• Diagnosis of radiculopathy and/or myelopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
• Neck and/or arm pain (at least 3 on the 0 - 10 numeric rating scale for pain.
• Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
• Abnormal sensation including hyperesthesia or hypoesthesia. and/or
• Abnormal reflexes.
• Symptomatic at one or two contiguous levels from C3 to C7.
• Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
• Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
• Degenerative spondylosis on CT or MRI.
• Disc herniation on CT or MRI.
• Neck Disability Index Score ≥ 30/100.
• Unresponsive to non-operative treatment (e.g., rest, heat, physical therapy, chiropractor, massage, pain medication) for approximately six weeks from the symptom onset; or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
• No previous surgical intervention at the involved levels or any subsequent, planned/staged surgical procedure at the involved or adjacent levels.
• Appropriate for treatment using an anterior surgical approach.

You may not qualify if:

• A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved levels.
• Documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing sagittal plane translation \>3.5 mm or sagittal plane angulation \> 20°.
• More than two cervical levels requiring surgical treatment.
• An immobile or spontaneously fused level adjacent to the levels to be treated.
• Severe pathology of the facet joints of the involved vertebral bodies.
• Previous surgical intervention at either one or both of the involved levels or at adjacent levels.
• History of trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
• Previously diagnosed with osteomalacia;
• Any of the following that may be associated with an increased risk osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan is required to determine eligibility). If the level of bone mineral density (BMD) on DEXA scan is a T score of -2.5 or worse (i.e., -2.6, - 2.7, etc.) the subject is ineligible for the study.
• Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds.
• Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture.
• Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
• Taking bisphosphonate medication for the treatment of osteoporosis.
• Chronic use of high dose steroids.
• Reported active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer) unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years.

Sponsors & Collaborators

• Zetagen Therapeutics, Inc: lead

Study Sites (2)

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Prince of Wales Public Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Nervous System Malformations; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Julie Croft

CONTACT

0882494788; julie.croft@avancecro.com

Study Design

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

Model Details: ZetaFuse Bone Graft

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 2, 2023
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 24, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)