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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cervical Radiculopathy
- Sponsor
- Research Source
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Primary Outcome Measure:
- Status
- Enrolling by Invitation
- Last Updated
- 8 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
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:
- •Decreased disc height on radiography,) in comparison to a normal adjacent disc
- •Degenerative spondylosis
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.
- •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.
Outcomes
Primary Outcomes
Primary Outcome Measure:
Time Frame: 12 months
Number of participants with a 15% improvement in NDI score (based on 100% scale) compared to baseline