Actively Recruiting
Pilot Study of ZetaFuse™ 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
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
Official 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 enrollment
- Diagnosis of cervical radiculopathy and/or myelopathy with symptoms such as neck or arm pain (pain score at least 3/10), decreased muscle strength, abnormal sensation, or abnormal reflexes in nerve roots C3 through C7
- Symptomatic at one or two contiguous cervical levels from C3 to C7
- Radiographic evidence at treated level including decreased disc height, degenerative spondylosis, or disc herniation on CT, MRI, or X-ray
- Neck Disability Index Score of 30/100 or higher
- Unresponsive to non-operative treatment for about six weeks or worsening symptoms despite treatment
- No previous surgery at the involved or adjacent levels and no planned additional surgeries at these levels
- Suitable for anterior surgical approach
- Skeletally mature at surgery
- Medically cleared for surgery
- If female of child-bearing potential, non-pregnant, not nursing, and agrees to avoid pregnancy during study
- Willing and able to comply with study plan
- Signed informed consent
- Willing 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 needing surgery at involved levels
- Cervical instability shown by dynamic X-rays with translation >3.5 mm or angulation >20°
- More than two cervical levels needing surgery
- Immobile or fused adjacent level to treated vertebrae
- Severe facet joint pathology at involved vertebral bodies
- Previous surgery at involved or adjacent levels
- History of trauma causing significant injury to C3-C7 spine
- Diagnosed osteomalacia
- Increased osteoporosis risk factors including postmenopausal non-Black female over 60 years under 140 pounds, history of non-traumatic fractures, bisphosphonate use, or chronic high-dose steroids; T score worse than -2.5 on DEXA scan
- Active or recent invasive malignancy (except non-melanoma skin cancer) without 5 years symptom-free
- Active infection systemically or at surgical site
- Insulin-dependent diabetes
- Tobacco use without agreement to quit before surgery
- Chronic or acute kidney failure or history of kidney disease
- Mental incompetence
- Prisoner status
- Current or recent alcohol or drug abuse treatment
- Involvement in current or pending spinal condition litigation
- Use of drugs interfering with bone metabolism within two weeks before surgery (excluding routine perioperative anti-inflammatory drugs)
- Endocrine or metabolic disorders affecting bone formation
- Conditions requiring post-op medications that affect implant stability
- Participation in investigational therapy within 28 days before surgery or planned during 16 weeks after implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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