Treatment of One and/or Two Level Cervical Degenerative Disc Disease

Study Purpose

The objective of this study is to collect clinical and radiographic outcomes using the CONDUITâ„¢ Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female subject; at least 18 years of age. 2. 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: 1. Neck and/or arm pain of at least 30/100 mm on the visual analogue scale (VAS) scale. 2. Decreased muscle strength of at least one level on the clinical evaluation (0 to 5) scale. 3. Abnormal sensation including hyperesthesia or hypoesthesia; and/or. 4. Abnormal reflexes. 3. 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. 4. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following: 1. Decreased disc height on radiography,) in comparison to a normal adjacent disc. 2. Degenerative spondylosis. 3. Disc herniation. 5. NDI Score >30%. 6. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: 1. Approximately six weeks from radiculopathy or myelopathy with radiculopathy symptom onset; or. 2. Have the presence of symptoms or signs of nerve root/spinal cord compression despite continued non-operative, conservative treatment; or. 3. Sooner than 6 weeks for worsening symptoms of neurologic compromise. 7. Reported to be medically cleared for surgery. 8. 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. 9. Signed informed consent provided by subject.

Exclusion Criteria:

1. Have an active systemic infection or infection at the operative site. 2. Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C. 3. Have previous trauma to the C2 to T1 levels resulting in significant bony or disco- ligamentous cervical spine injury. 4. Have had any prior spine surgery at the operative level(s). 5. Have osteoporosis. 6. Have Paget's disease of bone, osteomalacia or any other metabolic bone disease other than osteoporosis (addressed above). 7. 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. 8. Have symptomatic cervical disc disease or significant cervical spondylosis at more than 2 levels. 9. Have a known allergy to titanium. 10. Are currently pregnant or breastfeeding at time of enrollment or have plans to become pregnant within the next three years. 11. Have rheumatoid arthritis, lupus, or other autoimmune disease affecting the musculoskeletal system. 12. Have diseases or conditions that would preclude accurate clinical evaluation in the opinion of the Investigator. 13. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids. High dose steroid use is defined as: 1. Daily, chronic use of oral steroids equivalent to 5 mg/day of prednisone or greater. 2. Daily, chronic use of inhaled corticosteroids (at least twice per day). 3. 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. 14. Have current or recent history (within 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) requiring intervention. 15. Have a Body Mass Index (BMI) > 40 kg/m2. 16. 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. 17. Have pending personal litigation relating to spinal injury (worker's compensation is not an exclusion). 18. Have a current history of heavy smoking (more than one pack of cigarettes per day). 19. Currently reside in a location, or anticipating a potential relocation, that may interfere with completion of follow-up examinations. 20. 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. 21. Have an uncontrolled seizure disorder.

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Research Source
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Enrolling by invitation
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Cervical Radiculopathy
Additional Details

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.

Arms & Interventions


: DePuy Synthes Cervical Plating System

All enrolled patients will receive CONDUIT Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System.


Device: - CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating System

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

DFW Center for Spinal Disorders, Fort Worth, Texas



DFW Center for Spinal Disorders

Fort Worth, Texas, 76132