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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy Synthes Conduit 3D printed titanium cages | Device | DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion rate | 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| NRS | Numeric Rating Scale for neck and arm pain | 24 months |
| NDI | Neck Disability Index | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing 3 to 4 level ACDF procedures from C2-T1
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center Neurological Surgery | Columbus | Ohio | 43219 | United States |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| SF36 RAND | Short Form 36 RAND | 24 months |
| Neurological assessment: Upper Extremity Strength | grip, biceps, triceps, delts, intrinsics, wrist extrinsic) measured on scale of 0-5 follwing INSCI assessment for Manual Muscle Testing (MMT) | 24 months |
| Cervical sagittal alignment | 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. | 24 months |
| Reoperation | Reoperation at cervical and thoracic levels while patient is enrolled in the study. Hardware removed, new hardware added | 24 months |
| number of days in the hospital | number of days in the hospital | up to 24 months |
| Adverse events | wound infection, dysphagia, hematoma, dysphonia, DVT, etc | 24 months |
| Neurological assessment: Sensory function (C2-C7 dermatome) | Pin prick sensation is assessed with a needle. Light touch sensation is assessed with a piece of tissue paper. | 24 months |
| Neurological assessment: Sensation is scored as absent (0), abnormal (1), or normal (2) | Reflexes (Biceps, Brachioradials, Triceps)-Upper and lower extremities should be examined for asymmetry in deep tendon reflexes. | 24 months |
| Neurological assessment: Hoffman's and Spurlings | Testing for positive or negative indication | 24 months |