Clinical Trial Search

Primary: Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain — 60; 72 percentage of participants — p=0.23

Primary: Avoidance of Neck Surgery — 24; 20; 3; 6 Participants

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

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

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

Primary: Rate of Overall Success — 70.4; 63.2 percentage of participants — p=0.995

Primary: Composite Clinical Success (CCS) Rate of the Simplify® Disc — 153; 105 Participants — p=0.017

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

Primary: Individual Patient Overall Success — 142; 98 participants

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

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

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

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: 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: Rate of Overall Success — 81.4; 69.4 percentage of participants — p=1.000

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

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

Primary: Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software. — 14.73 cm

Primary: Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) — -3.38; -2.30 score on a scale — p=0.057

Primary: The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score — 49.1; 68.5 percentage of participants

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAE) — 615 Participants

Primary: Individual Patient Overall Success — 127; 81; 67 participants

Primary: Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad) — 58.7; 67.7; 13.6; 59.7 units on a scale

Primary: Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) — 5; 33; 28; 2 participants

Primary: Range of Traction Forces — 13.82; 38.3; 65.08; 17.19 Newtons (N)

Primary: Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable — 7.1; 5.8 units on a scale

Primary: Percent of Peak Activation (%PA) — 51.72; 61.20; 88.1; 80.80 Percentage of Peak Activation (%PA)

Primary: C2-C7 Lordosis — 11.0; 10.9 °

Primary: Rate of Overall Success — 80.9; 59.9 percentage of participants — p=<0.001

Primary: Bone Fusion With CT(Postoperative 6 Months) — 26; 28 participants