Cervical RadiculopathyNCT05812092
Treatment of One and/or Two Level Cervical Degenerative Disc Disease
An observational study of Cervical Radiculopathy, run by Research Source at 1 site in United States.
Trial summary
The objective of this study is to collect clinical and radiographic outcomes using the CONDUIT™ Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Mar 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or female subject; at least 18 years of age. Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C2 through T1.
Who may be able to join
- Male or female subject; at least 18 years of age
- Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C2 through T1, including at least one of the following:
- Neck and/or arm pain of at least 30/100 mm on the visual analogue scale (VAS) scale
- 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 cervical disc disease, facet arthropathy, or cervical spinal stenosis at 1 or 2 levels between C2 and T1, suitable for treatment with anterior discectomy, decompression, and fusion
- 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,) in comparison to a normal adjacent disc
- Degenerative spondylosis
- Disc herniation
- NDI Score >30%.
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
- Approximately six weeks from radiculopathy or myelopathy with radiculopathy symptom onset; or
- Have the presence of symptoms or signs of nerve root/spinal cord compression despite continued non-operative, conservative treatment; or
- Sooner than 6 weeks for worsening symptoms of neurologic compromise.
- Reported to be medically cleared for surgery.
- Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
- Signed informed consent provided by subject.
Who cannot join
- Have an active systemic infection or infection at the operative site.
- Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
- Have previous trauma to the C2 to T1 levels resulting in significant bony or disco- ligamentous cervical spine injury.
- Have had any prior spine surgery at the operative level(s).
- Have osteoporosis
- Have Paget's disease of bone, osteomalacia or any other metabolic bone disease other than osteoporosis (addressed above).
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- Have 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.
- Have symptomatic cervical disc disease or significant cervical spondylosis at more than 2 levels.
- Have a known allergy to titanium.
- Are currently pregnant or breastfeeding at time of enrollment or have plans to become pregnant within the next three years.
- Have rheumatoid arthritis, lupus, or other autoimmune disease affecting the musculoskeletal system
- Have diseases or conditions that would preclude accurate clinical evaluation in the opinion of the Investigator
- Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
- High dose steroid use is defined as:
- Daily, chronic use of oral steroids equivalent to 5 mg/day of prednisone or greater.
- Daily, chronic use of inhaled corticosteroids (at least twice per day).
- Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40mg prednisone equivalent within one month of the study procedure.
- Have current or recent history (within 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
- Have a Body Mass Index (BMI) > 40 kg/m2.
- Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents). High dose steroid use as defined in Exclusion Criterion 13.
- Have pending personal litigation relating to spinal injury (worker's compensation is not an exclusion).
- Have a current history of heavy smoking (more than one pack of cigarettes per day).
- Currently reside in a location, or anticipating a potential relocation, that may interfere with completion of follow-up examinations.
- Have mental illness or belonged to a vulnerable population, as determined by the investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements.
- Have an uncontrolled seizure disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
DFW Center for Spinal Disorders
Fort Worth, Texas, 76132
About this study
Official title: A Prospective Clinical/Radiological Outcome Study of the CONDUIT™ Interbody Cervical System With Supplemental Fixation for the Treatment of One and/or Two Level Cervical Degenerative Disc Disease and/or Cervical Spinal Instability
The objective of this study is to collect clinical and radiographic outcomes using the CONDUIT™ Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System.
Read the detailed description
The primary aim of this study is to evaluate the performance of the CONDUITTM Interbody Cervical System in reducing pain and degree of disability as measured using the Neck Disability Index (NDI). Recruitment will occur from the patient population of the investigator. All patients will be evaluated for participation in the study by using the inclusion/exclusion listed below. Subjects need to meet all the inclusion and none of the exclusion. The responsibility is exclusively maintained by the investigator of any potential study participant as defined by the inclusion/ exclusion. Patients will consent to participating in the study, prior to any study procedures.
- Conditions
- Cervical Radiculopathy
- Being tested
- CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating System
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating SystemDevice
CONDUIT Interbody Cervical System will be inserted between C2 through T1 and fixated using a DePuy Synthes Cervical Plating System at 1 or 2 levels.
| Study group | Role | What they receive |
|---|---|---|
| DePuy Synthes Cervical Plating System | All enrolled patients will receive CONDUIT Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System. Receives: Device: CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure:
Number of participants with a 15% improvement in NDI score (based on 100% scale) compared to baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 May 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Source
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812092
- Sponsor's protocol ID
- ONRI-OP-001
- Status last verified
- Aug 2025
- First submitted
- 31 Mar 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical/Radiological Outcome Study of the CONDUIT™ Interbody Cervical System With Supplemental Fixation for the Treatment of One and/or Two Level Cervical Degenerative Disc Disease and/or Cervical Spinal Instability
- ClinicalTrials.gov ID
- NCT05812092
- Acronym / sponsor ID
- ONRI-OP-001
- Conditions
- Cervical Radiculopathy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Research SourceResearch network
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Apr 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 objective of this study is to collect clinical and radiographic outcomes using the CONDUIT™ Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System.
Detailed description
The primary aim of this study is to evaluate the performance of the CONDUITTM Interbody Cervical System in reducing pain and degree of disability as measured using the Neck Disability Index (NDI). Recruitment will occur from the patient population of the investigator. All patients will be evaluated for participation in the study by using the inclusion/exclusion listed below. Subjects need to meet all the inclusion and none of the exclusion. The responsibility is exclusively maintained by the investigator of any potential study participant as defined by the inclusion/ exclusion. Patients will consent to participating in the study, prior to any study procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DePuy Synthes Cervical Plating System | – | Device: CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating SystemAll enrolled patients will receive CONDUIT Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female subject; at least 18 years of age. Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C2 through T1.
Key inclusion criteria (19 listed)
- Male or female subject; at least 18 years of age
- Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C2 through T1, including at least one of the following:
- Symptomatic cervical disc disease, facet arthropathy, or cervical spinal stenosis at 1 or 2 levels between C2 and T1, suitable for treatment with anterior discectomy, decompression, and fusion
- Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
- NDI Score >30%.
Key exclusion criteria (25 listed)
- Have an active systemic infection or infection at the operative site.
- Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
- Have previous trauma to the C2 to T1 levels resulting in significant bony or disco- ligamentous cervical spine injury.
- Have had any prior spine surgery at the operative level(s).
- Have osteoporosis
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 |
|---|---|---|
| CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating SystemCONDUIT Interbody Cervical System will be inserted between C2 through T1 and fixated using a DePuy Synthes Cervical Plating System at 1 or 2 levels. | Device | DePuy Synthes Cervical Plating System |
Primary outcome
Primary Outcome Measure:
Time frame: 12 months
Number of participants with a 15% improvement in NDI score (based on 100% scale) compared to baseline
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 22 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Radiculopathy, run by Research Source at 1 site in United States.
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 19 inclusion and 25 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: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure: (time frame: 12 months). 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 22 Aug 2025.