The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy. Implantation of the device will result in artificial replacement of a pathologically damaged or surgically removed cervical disc. Use of the device also obviates the need to harvest bone graft from the patient's iliac crest, a common and painful part of current surgical techniques. The NeoDisc is indicated for cervical spinal arthroplasty in skeletally mature subjects with symptomatic cervical disc disease at one level from C3 to C7. Symptomatic cervical disc disease is defined as image-confirmed herniated disc, spondylosis, and/or loss of disc height, with functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
488
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.
San Diego Center for Spinal Disorders
La Jolla, California, United States
Improve in NDI by ≥ 15 pnts at 24 mo compared to Baseline; No device failures requiring revision, re-op or removal; No major complications,i.e.,vascular or neurological injury; Maintenance or improvement of neurologic status
Time frame: August 2010
ROM; Fusion/migration of device; SF-36 imp of ≥15% at 24 months comp to Baseline; VAS imp of > 20 mm at 24 months comp to Baseline; Disc ht from lateral x-ray showing maintenance or imp from Baseline at 24
Time frame: August 2010
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Diagnostic and Interventional Surgical Center
Marina del Rey, California, United States
The Spine Institute
Santa Monica, California, United States
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, United States
Rocky Mountain Spine Arthroplasty (RMA Ortho)
Loveland, Colorado, United States
Florida Spine Specialists
Fort Lauderdale, Florida, United States
Florida Research Network, LLC
Gainesville, Florida, United States
Lyerly Baptist
Jacksonville, Florida, United States
Optim Healthcare
Savannah, Georgia, United States
OAD Orthopaedics
Warrenville, Illinois, United States
...and 12 more locations