Cervical Artificial Disc IDE CLINICAL STUDY OVERVIEW

Table of Contents Clinical Study Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Study Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....

Clinical Study Objective The objective of this Investigational Device Exemption (IDE) study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc compared to anterior cervical discectomy and fusion (ACDF) surgery for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space in patients who have failed at least 6 weeks of conservative treatment. Study Design The SECURE®-C IDE study was a prospective, two-arm, randomized, unmasked,...

Clinical Study Inclusion Criteria 1. Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurologic deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following: • Herniated nucleus pulposus; • Spondylosis (defined by presence of osteophytes); or • Loss of disc height Exclusion Criteria 1. More than one vertebral level requiring treatment 2. Prior fusion surgery adjacent to the level being treated 3. Prior surgery at the level to be treated 4. Clinically compromised vertebral bodies...

Clinical Study Results Patient Accounting and Demographics Patient accounting includes the number and percentage of patients with any data and efficacy (primary endpoint) data. Demographics were similar for both the randomized SECURE®-C and ACDF treatment groups. A breakdown of the data for all randomized patients is provided in the tables below for comparison. PATIENT ACCOUNTING Patients/Data Accounting Randomized SECURE®-C Patients Treated (Randomized) 151 Patients with Any Data at 24 Months 138 Follow-up Rate (Any Data) at 24 Months 93.2% Patients with Efficacy Data at 24 Months Follow-up...

Clinical Study Results Neck Disability Index Both cohorts showed an improvement in their respective Neck Disability Index (NDI) scores from baseline to 24 months postoperative. Eighty-nine percent (89.2%) of randomized SECURE®-C patients demonstrated clinically significant (>15 point) improvement in NDI compared to 84.5% of ACDF patients at the 24 month postoperative visit. Ninety-one percent (91.4%) of randomized SECURE®-C patients demonstrated at least a 25% improvement in NDI compared to 87.1% of ACDF patients at 24 months. Non-inferiority oftheSECURE®-C group was demonstrated at all postoperative...

Clinical Study Results Mean Visual Analog Scale (VAS) neck and arm pain scores improved in both the randomized SECURE®-C and ACDF treatment groups. Both cohorts demonstrated an improvement in neck and arm (right and left) VAS scores from baseline to the 24 month time point. For VAS improvement of at least 20mm (out of the 100mm scale) or zero arm postoperative pain, non-inferiority of SECURE®-C to ACDF was demonstrated for improvement in VAS neck, right and left arm pain at 24 months. Study Viiits Patient Satisfaction Overall, randomized patients who received the SECURE®-C implant were satisfied...

Clinical Study Results Radiological Assessment Radiographic evaluations were performed at each time point for both treatment groups. Anterior-posterior (AP) and lateral films were evaluated at each follow-up timepoint and flexion-extension films were evaluated at 6 months, 12 months and 24 months postoperative. Eighty-nine percent (89.1%) of ACDF patients exhibited radiographic fusion at 24 months (defined radiographically as bridging trabecular bone and range of motion <3mm in translation and <2° in rotation). Radiographic data provided evidence of motion (>4°) at the treated level in 84.6%...

Clinical Study Results Range of Motion and Disc Height SECURE®-C is designed to allow motion in the cervical spine. SECURE®-C is also designed to allow for AP translation during Randomized SECURE®-C patients exhibited a mean range of motion. The randomized SECURE®-C group demonstrated a motion (ROM) of 9.3° in flexion-extension at 24 months, mean ROM of 1.2mm in translation at 24 months aftersurgery. 85% of patients treated with the SECURE®-C who returned for 24 month follow-up had ^4° of flexion-extension motion Mean disc hei§ht was 57mm for the randomized SECURE®-C or maintenance of motion...

Clinical Study Results Adverse Events Adverse events were reported even if they occurred past the 24 month time period. The adverse event rate was similar for both treatment groups. Approximately 71% of all SECURE®-C patients experienced one or more adverse event, compared to approximately 79% of all ACDF patients. Secondary Surgeries Secondary surgeries were reported even if they occurred past the 24 month time period. All secondary surgical procedures at the index level were recorded through the 24 month follow-up period and later. The incidence of secondary surgery at the index level was 2.5%...

Overall Success and Conclusions Overall Success A patient was considered a success at 24 months if all of the following criteria were met: • • • • Pain/disability improvement of at least 25% in NDI at 24 months compared with the score at baseline N o device failures requiring revision, reoperation, removal, or supplemental fixation Absence of major complications defined as major vessel injury, neurologic damage or nerve injury For fusion control patients only, radiographic fusion, as defined radiographically by the presence of bridging trabecular bone and range of motion ≤3mm in translation and...