Thanks Sue, for your post. You reminded me of something that I took for granted, but should spell out explicitly: many of the present (and hopefully future) contraindications for ADR could be (or should be) shared with fusion procedures.
I’ve shared some of these indications in other posts, but it is definitely worth repeating. A “sampling” of these contraindications is below (cervical, lumbar and different mfrs). It is meant to an instrument or as a guide for the patient that MUST consider the many criteria that may or may not be part of the qualification process. In other words, do your homework!
Sue, please keep us posted on your future surgery in another post, and good luck with your procedure….
CerviCore™ Intervertebral Disc Clinical Study
Exclusion criteria (key criteria):
1. Axial neck pain or referred shoulder pain alone (without radicular symptoms).
2. Radicular symptoms in the distribution of more than one cervical nerve root/disc.
3. Previous cervical surgery including: any discectomy, any anterior cervical fusion, or any posterior cervical fusion or instrumentation. (This is not intended to exclude a patient with a prior laminectomy/laminotomy at a level that is not the target or adjacent level.)
4. History of metabolic bone disease
5. Post-menopausal woman with a DEXA scan hip t-score of < -2.5.
6. Taking any of the following medications:
a. Chronic oral or IV corticosteroid therapy (this is not intended to exclude inhalation medications for asthma),
b. Medications known to potentially interfere with bone/soft tissue healing (e.g. methotrexate),
c. Medications which increase bone-mineral density (e.g. Fosamax®, Didronel®).
7. Diabetes mellitus requiring daily insulin management.
8. Has any of the following:
a. progressive neuromuscular disease;
b. rheumatoid arthritis;
c. active malignancy within the last 15 years (unless the malignancy was treated with curative intent and there have been no clinical signs or symptoms for at least 5 years);
d. active hepatitis;
e. AIDS, ARC, or is HIV positive;
f. cervical myelopathy at any cervical level. (This is not intended to exclude cervical myelopathy at the level to be treated due to a soft disc herniation within the past 12 months that can be decompressed by an anterior discectomy);
g. syringomyelia at any spinal level;
h. any condition that would interfere with patient self-assessment of pain, function or quality of life.
9. Pregnant or is considering pregnancy within the next 3 years (excluded due to x-ray requirements).
Kineflex™ Lumbar Artificial Disc Implant
Exclusion criteria overview
Patients who meet any of the following criteria are excluded from participating in this study:
1. Any back or leg pain of unknown origin;
2. Previous trauma to the study treatment level, resulting in compression or bursting;
3. Previous retroperitoneal surgery, or sufficient previous surgeries that would preclude using an anterior approach;
4. Other spinal surgery at affected level;
5. Previous thoracic or lumbar fusion;
6. Documented abnormal abdominal vessel or muscular/fascial pathology or morphology;
7. Degenerative spondylolisthesis with greater than 3 mm slippage at study level;
8. Isthmic (spondylolytic) spondylolisthesis at study level;
9. Spondylitis (i.e., inflammation of the spine) at study level;
10. Documented significant spinal, foraminal or lateral stenosis at study level;
11. Disc space height ≤ 3 mm at study level;
12. Documented presence of free nuclear fragment at study level;
13. Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray;
14. Scoliosis of the lumbar spine with greater than 11° coronal deformity;
15. Metabolic bone disease;
16. Active systemic infection;
17. Active malignancy or history of metastatic malignancy;
18. Any terminal or autoimmune disease;
19. Any other disease, condition or surgery which might impair healing;
20. Recent history of chemical or alcohol dependence;
21. Current or extended use of any drug known to interfere with bone or soft tissue healing;
22. Known metal allergy;
23. Morbid obesity (BMI >40 or more than 100 pounds overweight);
24. Transitional vertebrae at level to be treated that has not clearly fused;
25. Pregnancy at time of enrollment, since this would contraindicate abdominal surgery.
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