Total Disc Replacement at Non-Contiguous Levels (C3-4 and C5-6) Should Be Denied
The requested total disc replacement at C3-4 and C5-6 must be denied because these levels are non-contiguous (separated by the normal C4-5 level), which violates absolute FDA approval criteria and established clinical guidelines that mandate contiguous levels only for cervical arthroplasty. 1
Critical Contraindications Present
Non-Contiguous Level Violation
- All FDA-approved cervical total disc replacement devices are indicated exclusively for contiguous levels between C3-C7 1
- The C3-4 and C5-6 levels are separated by the intervening C4-5 disc space, making this a non-contiguous configuration 2
- Multilevel cervical arthroplasty studies specifically define their populations as receiving "contiguous" implants at adjacent levels (e.g., C5-6 and C6-7, or C3-4 and C4-5) 2
- Hybrid constructs (TDR-ACDF-TDR) exist for non-contiguous disease, but pure arthroplasty at non-contiguous levels lacks FDA approval and safety data 2, 3
Unaddressed Osteoporosis Risk
- This 51-year-old female with history of gastric sleeve surgery represents high risk for osteoporosis and has never been tested 4
- Gastric sleeve surgery significantly impairs calcium and vitamin D absorption, necessitating supplementation (which she is taking) 4
- The MCG criteria explicitly require "no osteoporosis" as an absolute contraindication, yet bone density has never been assessed 4
- Cervical arthroplasty requires adequate bone quality for endplate fixation; osteoporotic bone increases risk of subsidence and implant failure 5
Cervical Instability Concerns
- The patient has documented retrolisthesis at both proposed surgical levels: 2mm at C3-4 and trace at C5-6 4
- MCG criteria require "absence of sagittal plane translation of more than 3mm on lateral flexion-extension x-rays" 4
- While the measured retrolisthesis is below 3mm threshold, flexion-extension radiographs are mandatory to definitively rule out dynamic instability before arthroplasty 4
- Static MRI cannot adequately assess segmental instability 4
Appropriate Alternative: Anterior Cervical Decompression and Fusion
ACDF Meets All Clinical Indications
- The patient has appropriate clinical presentation: 6 years of progressive neck pain, bilateral shoulder pain, right arm tingling, and objective 4/5 weakness in left deltoids and triceps 4
- MRI demonstrates large disc herniations at both C3-4 and C5-6 causing spinal cord flattening, which correlates with her myeloradiculopathy symptoms 4
- She has failed adequate conservative management: >6 weeks physical therapy, multiple cervical injections with diminishing efficacy, acetaminophen, heat, ice, massage, and chiropractic care 4
- ACDF provides 80-90% success rate for arm pain relief and 90.9% functional improvement in cervical radiculopathy with myelopathic features 4
ACDF at C3-4 and C5-6 is Guideline-Concordant
- Two-level ACDF at non-contiguous levels is an established, FDA-approved procedure with robust long-term outcome data 4
- The American Association of Neurological Surgeons recommends ACDF for patients with progressive cervical radiculopathy with myelopathic features (spinal cord flattening on MRI) refractory to conservative management 4
- Anterior cervical plating for 2-level disease reduces pseudarthrosis risk from 4.8% to 0.7% and improves fusion rates from 72% to 91% 4
- ACDF provides more rapid relief (within 3-4 months) of arm/neck pain, weakness, and sensory loss compared to continued conservative treatment 4
Addressing the C4-5 Level
- The imaging shows "still mobility at C3-4 level and a little bit of mobility at C5-6 level" but no mention of C4-5 pathology 4
- X-rays demonstrate "disc degeneration without any stenosis at the C6-7 level" but C4-5 is not described as pathologic 4
- If C4-5 is truly normal, a hybrid construct (ACDF at C3-4, skip C4-5, ACDF at C5-6) would be the appropriate surgical approach 2, 3
- If C4-5 has any degree of degeneration, three-level contiguous ACDF (C3-4, C4-5, C5-6) would be preferable to avoid adjacent segment disease at an intervening mobile segment 4
Common Pitfalls to Avoid
- Do not proceed with arthroplasty without bone density assessment in high-risk patients (postmenopausal age, gastric sleeve, vitamin D supplementation needs) 4, 5
- Do not rely on static imaging alone to assess stability; flexion-extension radiographs are mandatory before arthroplasty 4
- Do not attempt to use arthroplasty devices outside their FDA-approved indications (non-contiguous levels, >2 levels) as this exposes the patient to unproven risk and creates medicolegal liability 1
- Do not ignore documented retrolisthesis, even if below 3mm threshold, without dynamic imaging to assess for instability 4
Recommended Clinical Pathway
- Obtain DEXA scan to assess bone mineral density given gastric sleeve history and age 4
- Obtain flexion-extension cervical radiographs to definitively assess stability at C3-4 and C5-6 4
- Proceed with two-level ACDF with anterior cervical plating at C3-4 and C5-6 (or three-level if C4-5 is also pathologic) 4
- Consider hybrid construct only if C4-5 is definitively normal on all imaging modalities 2, 3