Radiculopathy, CervicalNCT05971329
Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease
A study testing Cervical Fusion (ZetaFuse™ Bone Graft) in people with Radiculopathy, Cervical and Myelopathy Cervical, run by Zetagen Therapeutics, Inc at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiculopathy, Cervical, Myelopathy Cervical, Neurological Abnormality
- What is being tested?
- Cervical Fusion (ZetaFuse™ Bone Graft)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Skeletally mature at the time of the surgery.
- Medically cleared for surgery.
- If a female of child-bearing potential, subject is non-pregnant, nonnursing, and agrees not to become pregnant during the study period.
- Willing and able to comply with the study plan.
- Signed written Patient Informed Consent Form.
- Willing to discontinue use of non-steroidal anti-inflammatory drugs (NSAIDs) from one week before the surgery to 3 months after the surgery.
Who cannot join
- 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.
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- 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.
- Overt or active systemic infection, or infection at the operative site.
- Insulin dependent diabetes.
- A tobacco user who does not agree to suspend smoking prior to surgery.
- Chronic or acute renal failure or prior history of renal disease.
- Mentally incompetent (If questionable, obtain psychiatric consult).
- A prisoner.
- An alcohol and/or drug abuser currently or recently undergoing treatment for alcohol and/or drug abuse.
- Involved with current or pending litigation regarding a spinal condition.
- Received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate) excluding routine perioperative anti-inflammatory drugs.
- A history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers- Danlos Syndrome, or osteogenesis imperfecta).
- A condition that requires post-operative medications that interfere with the stability of the implant, such as steroids. (This does not include low dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs).
- Received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation with the ZetaFuse™ Bone Graft device.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Prince of Wales Private Hospital
Randwick, New South Wales, 2031
Ralph Mobbs, MD, 0296504766, ralph@drmobbs.com.au
- Recruiting
Prince of Wales Public Hospital
Randwick, New South Wales, 2031
Ralph Stanford, MD, 0296504893, ralph.stanford@health.nsw.gov.au
About this study
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.
Read the detailed description
The indication under investigation is for use in the skeletally mature patients for fusion of one or two contiguous vertebral bodies in the cervical spine from C3-C7 following discectomy for intractable radiculopathy with or without neck pain, or myelopathy due to abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging:herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.
- Conditions
- Radiculopathy, Cervical, Myelopathy Cervical, Neurological Abnormality, Disc Disease, Disc Degeneration
- Being tested
- Cervical Fusion (ZetaFuse™ Bone Graft)
- Medical subject headings
- Radiculopathy, Nervous System Malformations, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Fusion (ZetaFuse™ Bone Graft)Device
Fusion of the C3-C7 cervical vertebral bodies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cervical Fusion (ZetaFuse™ Bone Graft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post surgery
Secondary outcomes (1)
Quality of Life via Short Form (SF12v2) Health Survey
SF12 measures quality of life, pain, and activity in a survey using 12 questions, with scores >50 showing a better outcome
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study startSep 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy, CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ZetaFuse Bone Graft
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zetagen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971329
- Sponsor's protocol ID
- ZG-2022-003
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT05971329
- Acronym / sponsor ID
- ZG-2022-003
- Conditions
- Radiculopathy, Cervical, Myelopathy Cervical, Neurological Abnormality, Disc Disease, Disc Degeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zetagen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The indication under investigation is for use in the skeletally mature patients for fusion of one or two contiguous vertebral bodies in the cervical spine from C3-C7 following discectomy for intractable radiculopathy with or without neck pain, or myelopathy due to abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging:herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ZetaFuse Bone Graft
| Arm | Type | Receives |
|---|---|---|
| Pilot Study of ZetaFuse Bone Graft for the Treatment of Cervical Degenerative Disc Disease | Experimental | Device: Cervical Fusion (ZetaFuse™ Bone Graft)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. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- 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:
- Neck Disability Index Score ≥ 30/100.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Fusion (ZetaFuse™ Bone Graft)Fusion of the C3-C7 cervical vertebral bodies | Device | Pilot Study of ZetaFuse Bone Graft for the Treatment of Cervical Degenerative Disc Disease |
Primary outcome
Subjects with Radiologic Determination of Bone Fusion of the Treated Cervical Vertebral Bones
Time frame: 1 year post surgery
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 secondary outcome
Quality of Life via Short Form (SF12v2) Health Survey
Time frame: 1 year post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Fusion (ZetaFuse™ Bone Graft) in people with Radiculopathy, Cervical and Myelopathy Cervical, run by Zetagen Therapeutics, Inc at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Croft (0882494788, julie.croft@avancecro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects with Radiologic Determination of Bone Fusion of the Treated Cervical Vertebral Bones (time frame: 1 year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.