Central Canal Stenosis, Foraminal Stenosis, Myelopathy Cervical, Radiculopathy
Conditions
Brief summary
The purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM. This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.
Detailed description
This is a prospective, single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis. 58 Patients undergoing 3 to 4 level ACDF procedures from C2-T1 will be enrolled. Patients will be implanted with DePuy Conduit Titanium ACDF cage (DePuy Synthes, Raynham, MA). A retrospective comparision group will be used. The retrospective group will include 58 consecutive patients undergoing 3-4 level ACDFs with milled allograft. This single-centered study will enroll up to 58 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries. The inclusion/exclusion criteria are listed below.
Interventions
DEVICEDePuy Synthes Conduit 3D printed titanium cages
DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM
Sponsors
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old * Symptomatic multi-level degenerative cervical spondylosis necessitating anterior cervical arthrodesis in the subaxial cervical spine (between C2-T1). * Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC) * Cervical x-rays at 24 months (±60 days; retrospective comparison group only)
Exclusion criteria
* Traumatic spinal fractures or spinal cord injury * Previous cervical fusion surgery * Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator * Severe co-morbidities (e.g., heart, respiratory, or renal disease) * Recent (\<3 yrs) or co-incident spinal tumor or infection * Concurrent involvement in another investigational drug or device study that could confound study data (prospective exclusion only) * History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up * Subjects who are pregnant or plan to become pregnant in the next 24 months * Prisoner * Other contraindications for DePuy Conduit 3D printed titanium cage implant (prospective exclusion only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion rate | 24 months | based on postoperative X-ray: presence of bone trabeculae across graft-host interface, absence of radiolucent gap between graft and adjacent vertebral body, restriction of motion to 2mm or less between adjacent vertebral spinous processes on flexion-extension lateral radiographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NDI | 24 months | Neck Disability Index |
| SF36 RAND | 24 months | Short Form 36 RAND |
| Neurological assessment: Upper Extremity Strength | 24 months | grip, biceps, triceps, delts, intrinsics, wrist extrinsic) measured on scale of 0-5 follwing INSCI assessment for Manual Muscle Testing (MMT) |
| Cervical sagittal alignment | 24 months | Standing radiographs of the sagittal spine to identify changes in functional sagittal; will measure the Cobb angle between the lower endplate of C2 and C7 (C2L-C7L angle) alignment after cervical fusion as determined by functional segments between cervicothoracic and thoracolumbar. Patient cervical 4 view x-rays pre-operatively and at follow-ups will be compared. |
| Reoperation | 24 months | Reoperation at cervical and thoracic levels while patient is enrolled in the study. Hardware removed, new hardware added |
| NRS | 24 months | Numeric Rating Scale for neck and arm pain |
| Adverse events | 24 months | wound infection, dysphagia, hematoma, dysphonia, DVT, etc |
| Neurological assessment: Sensory function (C2-C7 dermatome) | 24 months | Pin prick sensation is assessed with a needle. Light touch sensation is assessed with a piece of tissue paper. |
| Neurological assessment: Sensation is scored as absent (0), abnormal (1), or normal (2) | 24 months | Reflexes (Biceps, Brachioradials, Triceps)-Upper and lower extremities should be examined for asymmetry in deep tendon reflexes. |
| Neurological assessment: Hoffman's and Spurlings | 24 months | Testing for positive or negative indication |
| number of days in the hospital | up to 24 months | number of days in the hospital |
Countries
United States
Outcome results
None listed