Clinical Trial Search

Primary: To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and…

Primary: Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail) — 17 Events

Primary: Neurological Assessment for Motor Function and Reflexes/Sensory — 0; 0 participants

Primary: VAS for Lumbar Pain in 3 Months — 2.63; 4.53 units on a scale — p=0.05

Primary: Overall Success — 137; 110; 28; 13 participants who are successes

Primary: Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days — -41.7; -34.2 units on a scale — p=0.0263

Primary: Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up. — -2.4; -0.56 units on a scale

Primary: Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at…

Primary: Overall Success at 24 Months Relative to Baseline — 42.2; 28.3; 61.9; 52.8 percentage of participants — p=<0.05

Primary: Number of Subjects With Successful Radiographic Fusion — 90 Participants

Primary: Neurological Assessment for Motor Function and Reflexes/Sensory — 0; 0 participants

Primary: the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position — 17; 18 Participants

Primary: Pain Assessed by Visual Analogue Scale — 5.63; 5.92 units on a scale

Primary: Pain and Disability Evaluation — 0.28; 0.15 scores from 0 to 1

Primary: Composite Definition of Study Success — 65.3; 73.7; 37.4; 69.7 percentage of subjects analyzed — p=0.0021

Primary: Change in the Numerical Pain Rating Scale — 5.96; 6.12; 6; 1.22 units on a scale

Primary: Neurological Assessment for Motor Function and Reflexes/Sensory — 0; 0 participants

Primary: Incidence of Successful Lumbar Fusion Measured Radiographically — 13; 11 Participants

Primary: Neck Disability Index — 17.9; 16.7 units on a scale from 0 to 100 — p=0.641

Primary: Neurological Assessment for Motor Function and Reflexes/Sensory — 0; 2 participants

Primary: Fusion Rates Per Level Using the Bridwell Interbody Grading Scale — 64; 50 Fusions

Primary: Radiographic Fusion — 66; 46; 37; 75 percentage of subjects

Primary: Pain Diary — 6.71; 5 units on a scale

Primary: Number of Participants With Composite Clinical Success (CCS) of Simplify Disc — 68; 132 Participants — p=<.001

Primary: Participants With Improved Patient Function — 7; 6 participants — p=1.0

Primary: Corneal Endothelial Cell Loss — 9.85; -3.68 Percent change

Primary: Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning — 47; 22; 6 Surgical plans

Primary: Overall Success — 45.1; 63.5; 66.7; 53.3 percentage of overall successes

Primary: Overall Success — 62.8; 53.2; 62.7 % of Subjects

Primary: Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.21 units on a scale — p=<0.0001