Burkus et al 1 (2010)
Prestige C-ADR
N = 541
Male: 46%
Mean age: 43.6 (22–73) y
C-ADR: n = 276
Male: 46.4%
Mean age: 43.3 (25–72) y
Fusion: n = 265
Male: 46.0%
Mean age: 43.9 (22–73) y |
Adults >18 years of age Single-level symptomatic DDD between C3-7 Intractable radiculopathy, myelopathy or both NDI scores ≥ 30 VAS neck pain scores ≥ 20 Preserved motion at the symptomatic level found in all included patients Unresponsive to ≥ 6 weeks conservative treatment or progressive neurological worsening despite conservative treatment No previous procedures at the operative level Negative for several radiographic findings, medications, and diagnoses |
Multilevel symptomatic DDD or evidence of cervical instability Sagittal plane translation of > 3.5 mm or sagittal plane angulation of >20° at a single level Symptomatic C2-C3 or C7-T1 disc disease Previous surgery at the involved level Severe facet joint disease at the involved level History of discitis Osteoporosis Metastases Medical condition that required long-term use of medication, such as steroid or nonsteroidal antiinflammatory drugs that could affect bone quality and fusion rates |
Sasso et al 2 (2011)
Bryan C-ADR
N = 463
Male: 48%
Mean age: 44.5 (25–78) y
C-ADR: n = 242
Male: 45.5%
Mean age: 44.4 (25–78) y
Fusion: n = 221
Male: 51.1%
Mean age: 44.7 (27–68) y |
DDD at single level between C3 and C7 Disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy 6 weeks minimum unsuccessful conservative unless myelopathy requiring immediate treatment CT, myelography and CT, and/or MRI demonstration of need for surgical treatment ≥21 years old Preoperative NDI ≥ 30 and minimum one clinical sign associated with level to be treated Willing to sign informed consent and comply with protocol |
Significant cervical anatomical deformity Moderate to advanced spondylosis Any combination of bridging osteophytes, marked reduction, or absence of motion Collapse of intervertebral disc space of > 50% normal height, radiographic signs of subluxation > 3.5 mm, angulation of disc space > 11° greater than adjacent segments, significant kyphotic deformity or reversal or lordosis Axial neck pain as solitary symptom Previous cervical spine surgery Metabolic bone disease Active systemic infection or infection at operative site Known allergy to components of titanium, polyurethane, ethylene oxide residuals Concomitant conditions requiring steroid treatment Daily insulin management Extreme obesity Medical condition which may interfere with postoperative management program or may result in death before study completion Pregnancy Current or recent alcohol and/or drug abuser Signs of being geographically unstable |
