By InvitationNot Applicable

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

United States50 participantsStarted 2021-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

Primary Outcome Measure:

Timeframe: 12 months

Trial details

NCT IDNCT05812092

SponsorResearch Source

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2027-03-01

View on ClinicalTrials.gov More Cervical Radiculopathy trials