The Oswestry Disability Index (ODI) is a validated instrument including items that relate to subjective symptomatology and activities of daily living (pain intensity, personal care, lifting, walking, sitting, standing, sex life, traveling). This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from O up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.

Health-related quality of life was evaluated in all study subjects using the SF-12v2 Health Survey. This shortened and simplified version of the SF-36 makes the questionnaire less ambiguous for patients. It has a self-administered form that makes it easy to read and complete, and that reduces missing responses. The physical and mental component summary scales, referred to as PCS-12 and MCS-12 were evaluated against published normative values and a 15% improvement in these scores was used as an assessment of success. In calculating the true value of a treatment, the scores from the SF-12v2 were converted into a utility index (SF-6D), which considered not only how many years a medical intervention could have added to a patient's life, but also the quality of that life. Use of the SF-6D did not expand the questions administered to the patients. The scale ranged from 0-100% with 100% being the best quality of life.

Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images were performed. Radiographic and qualitative assessments performed include:

• Device Condition: looks at both the cage inside the vertebrae and the hardware outside the vertebrae. It looks at whether or not the device is intact or not (subsidence or migration)
• Fusion/Non-fusion: whether bone has grown within the space between the spinal vertebrae. If fusion occurs, it results in Bony Bridging

At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).

At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows:

Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment.

Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference.

Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited.

Poor: symptoms or signs unchanged or worse.

The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.

The length of time the patient is under anesthesia were captured from the Anesthesia Record.

The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.

Abnormal result(s) of neuromonitoring systems (Train of Four, Electromyography (EMG), Triggered EMG, Somato Sensory Evoked Potential (SSEP) and Motor Evoked Potential (MEP)) utilized during the surgery were captured.

The length of hospital stay from the date of hospital admission to the date of discharge was calculated.

The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.

The types and dosages of any narcotics taken by the patient post-surgery were documented.

The study Case Report Forms did not include Race/Ethnicity

Evaluation of the improvement of the Right Hip VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.

Evaluation of the improvement of the Left Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.

Evaluation of the improvement of the Right Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms was captured and evaluated.

The evaluation of all adverse events including device related, procedure related and additional serious adverse events.

This is an analysis of the number of participants that reported any form of adverse event. Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events.

9 of the 30 SAE participants did not experience a non-SAE events. The other 21 participants had events in both categories

Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness was performed using Patient symptom Questionnaire (0-100mm analog scale with 100mm being the highest pain/weakness/numbness)

The overall number of patients participated in each interval differed from the number of patients that were evaluated for the body location measurements.

The Oswestry Disability Index (ODI) is a validated instrument including items that relate to subjective symptomatology and activities of daily living (pain intensity, personal care, lifting, walking, sitting, standing, sex life, traveling). This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from O up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.

131 patients started the study at Pre-op, 6 patients did not complete the survey; 125 started operative, 34 patients did not complete the survey at Discharge; 121 started the Post-operative interval, 4 patients did not complete the survey; 111 patients started at 3 Month interval, 4 patients did not complete the survey; All patients who started at 6 months and 24 months completed their surveys at their respective intervals.

Health-related quality of life was evaluated in all study subjects using the SF-12v2 Health Survey. This shortened and simplified version of the SF-36 makes the questionnaire less ambiguous for patients. It has a self-administered form that makes it easy to read and complete, and that reduces missing responses. The physical and mental component summary scales, referred to as PCS-12 and MCS-12 were evaluated against published normative values and a 15% improvement in these scores was used as an assessment of success. In calculating the true value of a treatment, the scores from the SF-12v2 were converted into a utility index (SF-6D), which considered not only how many years a medical intervention could have added to a patient's life, but also the quality of that life. Use of the SF-6D did not expand the questions administered to the patients. The scale ranged from 0-100% with 100% being the best quality of life.

The number analyzed in Mental Health and Physical Health rows for 6 Months and 12 Months differ due to the inability for a participant to complete the required forms for those two intervals.

Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images were performed. Radiographic and qualitative assessments performed include:

• Device Condition: looks at both the cage inside the vertebrae and the hardware outside the vertebrae. It looks at whether or not the device is intact or not (subsidence or migration)
• Fusion/Non-fusion: whether bone has grown within the space between the spinal vertebrae. If fusion occurs, it results in Bony Bridging

The numbers are different from the overall number analyzed due to the different number of people who participated in each visit's radiographic analysis

At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).

Patient self-assessment of the procedure at 12M and 24M

At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows:

Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment.

Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference.

Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited.

Poor: symptoms or signs unchanged or worse.

The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.

3 of 125 subjects did not have surgery time included. There were 12 staged procedures increasing the overall number of procedures to 134

The length of time the patient is under anesthesia were captured from the Anesthesia Record.

3 of 125 subjects did not have surgery time included. There were 12 staged procedures increasing the overall number of procedures to 134

The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.

11 of 125 subjects did not have blood loss included. There were 12 staged procedures increasing the overall number of procedures to 126.

Abnormal result(s) of neuromonitoring systems (Train of Four, Electromyography (EMG), Triggered EMG, Somato Sensory Evoked Potential (SSEP) and Motor Evoked Potential (MEP)) utilized during the surgery were captured.

The length of hospital stay from the date of hospital admission to the date of discharge was calculated.

The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.

All patients who participated in each interval were accounted for including the missing category

The types and dosages of any narcotics taken by the patient post-surgery were documented.

All patients who participated in each interval were accounted for including the missing category