1. Who is the ideal patient for this study?

Based on their experience, several members of the Applied Spine Technologies’ Scientific Advisory Board have identified stenotic patients with a stable Grade 1 Spondylolisthesis and less than 3mm translational motion (for whom surgeons most commonly perform a decompression only) as a logical selection.

2. What is the primary end point that measures the success of the treatment?

• End point must be satisfied at any time from six months through 24 months post-procedure and be maintained at the 24-month assessment
• Must demonstrate a reduction in leg pain from baseline of at least 20mm on a 100mm visual analog scale
• Must demonstrate clinically significant improvement as defined by a minimum decrease of .5 as measured by the Zurich Claudication Questionnaire for both symptom severity and physical function
• Experience no major device-related complications
• The treated level requires no surgical revision, re-operation, removal or supplemental fixation

3. Why the Zurich Claudication Questionnaire (ZCQ) and not the NASS/AAOS that had been originally identified as the mechanism to evaluate patient satisfaction

• The ZCQ is a tool that has precedence at both the CMS and the FDA for the purpose of evaluating patients in clinical studies for spinal fixation and stabilization.
• The ZCQ is a tool developed specifically for the evaluation of clinical patients being treated for spinal stenosis.

4. Will I be able to schedule more than one patient per day?

Yes, we will accommodate you in enrolling patients in this study

• We will provide one instrument set per case.
• Only one case can be performed with each instrument set.

5. How do I schedule a patient for inclusion in the study?

Your Clinical Coordinator will handle all the logistics for the study.

6. What materials will be available for patient education and enrollment?

• All investigators will be given a Lucite bone model with which to demonstrate the proper position of the implants.
• All investigators will be given a supply of patient brochures with which to explain the study to the patient and offer justification for recommending this surgical intervention.
• Investigators will be instructed to utilize the Applied Spine web site to allow the patient to review animated demonstrations of the implant and its intended benefits

7. Is the Stabilimax NZ® MRI compatible?

Yes. The material components of Stabilimax NZ include cobalt chromium, Elgiloy® and titanium alloy, all of which are non-ferromagnetic.

8. Is a DEXA scan required?

Only when the results of the Simple Calculated Osteoporosis Risk Estimate (SCORE) indicate that a DEXA will be required

9. What kind of radiographic data will be required?

• MRI and plain films at baseline
• Post-procedure films at discharge
• Plain films at three months, six months, one year and two years
• MRI at one year and two years, post-op

10. Will the operating room nurses be trained on the procedure?

Yes, training for O.R. Nurses and the Central Processing Technicians will occur after you have attended the surgeon training session.

11. Can I remove a screw and replace that screw with one that is larger in diameter without this being considered a protocol deviation?

As long as one Stabilimax NZ screw is removed and is replaced by a larger Stabilimax NZ screw, it is not considered a deviation from the protocol.

12. Are the Stabilimax NZ pedicle screws compatible with other pedicle screw-based systems?

No.

13. Can more than two levels be implanted with the Stabilimax NZ in this study?

No. The study protocol only allows a maximum of two contiguous levels.

14. Can I use the Stabilimax NZ on L4-5, fuse L3-4 and then implant the Stabilimax NZ on L2-3?

No. The Clinical Study Protocol allows for only contiguous levels with the Stabilimax NZ, and, for the purpose of this study, there cannot be a fusion in conjunction with the use of Stabilimax NZ.