The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS 22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self- image/appearance (SA), mental health (MH) and satisfaction with treatment (ST).

The scores vary from 1 to 5 in which 5 is the best health quality of life of patients.

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 worsened.

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

The length of time the patient is under anesthesia was captured.

The amount of blood loss over the entire length of the surgery was captured.

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

The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the change in percentage of participants who were able to return to work without any restrictions

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

The study Case Report Forms did not include Race/Ethnicity

Number of participants with SAE and AE for the various intervals

This is an analysis of the number of participants that reported any form of adverse event. Overall participants with any AE or SAE. 5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.

Evaluation of the improvement of the Back VAS and Hip/Leg VAS (assessed together) 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 were captured and evaluated.

VAS scale ranged from 0 - 100mm with the 100mm accounting for the highest level of pain.

13 out of the 99 participants who returned at 24 months, did not complete the survey.

The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS 22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self- image/appearance (SA), mental health (MH) and satisfaction with treatment (ST).

The scores vary from 1 to 5 in which 5 is the best health quality of life of patients.

While 99 participants completed 24 month interval, 14 patients out of the 99 did not did not complete the survey.

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 worsened.

Patients who were rated based on the outcome of their treatment and would indicate either Excellent, Good or Fair/Satisfactory. No responses are shown under missing

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

186 patients had their surgery times recorded. There were 3 additional procedures staged increasing the overall number of units analyzed to 189.

The length of time the patient is under anesthesia was captured.

183 subjects had anesthesia time included. There were 3 staged procedures increasing the overall number of units analyzed to 186.

The amount of blood loss over the entire length of the surgery was captured.

187 patients had blood loss included. There were 3 additional procedures staged increasing the overall number of units analyzed to 190.

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

186 patients completed admit and discharge dates

The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the change in percentage of participants who were able to return to work without any restrictions

Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.

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

Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.