Actively Recruiting
Pilot Study of ZetaFuse32 Bone Graft for the Treatment of Cervical Degenerative Disc Disease
Led by Zetagen Therapeutics, Inc · Updated on 2025-04-24
10
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and early performance of the ZetaFuse Bone Graft in adults needing fusion of cervical vertebral bones C3 through C7 due to pain or neurological problems. It focuses on patients with confirmed cervical spine issues such as herniated discs, spondylosis, or disc height loss, who have symptoms including radiculopathy or myelopathy. The purpose is to assess fusion success and improvements in quality of life following surgery. Participants will receive the ZetaFuse Bone Graft packed into a PEEK interbody device during surgery to fuse one or two adjacent cervical vertebrae. This device is implanted through an anterior surgical approach to treat degenerative disc disease affecting the cervical spine levels C3 to C7. The study is a pilot clinical trial with no placebo or comparison group. During the study, participants will be monitored for bone fusion at one year post-surgery through radiologic imaging. Researchers will also assess quality of life using the Short Form (SF12v2) Health Survey at the same time point. The study includes medical clearance, adherence to medication restrictions, and follow-up visits to evaluate surgical outcomes and safety over time. Total participation may last up to one year after surgery.
CONDITIONS
Brief Title
Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 to 75 years (inclusive) at the time of enrollment.
- Diagnosis of cervical radiculopathy and/or myelopathy with symptoms such as neck/arm pain, decreased muscle strength, abnormal sensation, or abnormal reflexes.
- Symptoms affecting one or two contiguous cervical spine levels from C3 to C7.
- Radiographic evidence of pathology including decreased disc height, degenerative spondylosis, or disc herniation correlating to symptoms.
- Neck Disability Index Score of 30 or higher out of 100.
- Unresponsive to non-operative treatments for about six weeks or worsening symptoms despite such treatments.
- No previous surgery at the involved or adjacent spine levels.
- Suitable for anterior cervical surgical approach.
- Skeletally mature at surgery time.
- Medically cleared for surgery.
- Female participants of child-bearing potential must be non-pregnant, non-nursing, and agree to avoid pregnancy during the study.
- Willing and able to follow the study plan.
- Signed informed consent.
- Agree to stop NSAIDs from one week before to three months after surgery.
You will not qualify if you...
- Cervical spinal conditions other than symptomatic degenerative disc disease requiring surgery at involved levels.
- Cervical instability defined by specific measurements on dynamic X-rays.
- More than two cervical levels needing surgery.
- Immobile or fused adjacent cervical levels.
- Severe facet joint pathology at treated vertebrae.
- Previous surgical intervention at involved or adjacent levels.
- History of trauma causing significant cervical spine injury.
- Diagnosed osteomalacia.
- Increased osteoporosis risk factors with low bone density on DEXA scan.
- Active or recent invasive malignancy unless disease-free for at least five years.
- Active systemic or operative site infection.
- Insulin-dependent diabetes.
- Current tobacco users unwilling to quit before surgery.
- Chronic or acute kidney failure or history of kidney disease.
- Mental incompetence.
- Prisoners.
- Current or recent alcohol/drug abuse treatment.
- Involvement in spinal condition litigation.
- Recent treatment with drugs affecting bone metabolism (e.g., steroids) before surgery.
- Endocrine or metabolic disorders affecting bone formation.
- Conditions requiring post-operative medications that affect implant stability.
- Participation in other investigational therapy within 28 days before or planned 16 weeks after surgery.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge following surgery
Participants undergo surgical implantation of the ZetaFuse™ Bone Graft for cervical fusion and receive immediate post-operative care.
1 surgical procedure and hospital stay
Duration - 1 year post surgery
Participants are monitored for bone fusion and recovery with follow-up assessments including radiologic imaging and quality of life surveys.
Approximately 6 post-operative visits
Trial Site Locations
Total: 2 locations
1
Prince of Wales Private Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Prince of Wales Public Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
Research Team
J
Julie Croft
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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