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

Enrolling by invitation

Conditions studied: Cervical Radiculopathy

In brief

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.

Key facts

Study ID

NCT05812092

Run by

Research Source

People needed

50

Starts

2021-05-01

Expected to finish

2027-03-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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).
• 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.

Where it is running

• DFW Center for Spinal Disorders — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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