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

NCT05812092 | Enrolling By Invitation FDA Device

• 1 other identifier: ONRI-OP-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure:

  Number of participants with a 15% improvement in NDI score (based on 100% scale) compared to baseline

  12 months

Study Arms (1)

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

Interventions

CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating System DEVICE

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.

DePuy Synthes Cervical Plating System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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

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.

Sponsors & Collaborators

• Research Source: lead

Study Sites (1)

DFW Center for Spinal Disorders

Fort Worth, Texas, 76132, United States

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: May 1, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)