Two-Level Cervical Total Disc Replacement versus ACDF: Results of a Prospective, Randomized, Clinical Trial with 48 Months Follow-up

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1 Two-Level Cervical Total Disc Replacement versus : Results of a Prospective, Randomized, Clinical Trial with 48 Follow-up Prof Jean Paul Steib 1, MD; Reginald Davis, MD 2 1 Spine Surgery Dept, University Hospital, Strasbourg, France; 2 GBMC Healthcare, Baltimore, MD, USA

2 Study Design Multi-center, prospective, concurrently controlled, non-inferiority FDA IDE clinical trial. Investigational treatment: (Mobi-C ) Control: with anterior plate and allograft bone Patient Population: 33 two-level patients total randomized (2:1) Age range month follow-up rate (% patients with any data). : 89.% : 81.2% Radiographic imaging (CT, MRI, X-rays) was used to confirm at least one of the following conditions: Spondylosis Herniated nucleus pulposus Visible disc height reduction compared to adjacent levels Outcome Measures: NDI score VAS neck/arm pain Range of Motion Secondary Surgery Rates Radiographic Adjacent Segment Degeneration Patient Satisfaction & Recommendation Overall Success All radiographic conclusions were made by Medical Metrics Inc., and all outcome measures defined by FDA.

3 Mean NDI Score Change Mean NDI Score NDI Score Baseline 6 W 3 M 6 M 12 M 18 M 24 M 36 M 48 M Statistically significant lower scores between treatment groups (p<.5) when comparing mean change from baseline, using an unpaired t-test

4 VAS Score Change VAS Score VAS Neck Pain Score Baseline 6 W 3 M 6 M 12 M 18 M 24 M 36 M 48 M Statistically significant difference in improvement from baseline between treatment groups (t-test, p<.5)

5 VAS Score Change from Baseline VAS Score VAS Arm Pain Score Baseline 6 W 3 M 6 M 12 M 18 M 24 M 36 M 48 M

6 Range of Motion (Degrees) Range of Motion (Degrees) 12 Superior Index Level ROM Baseline F/E Baseline 3 Inferior Index Level ROM LB F/E LB F/E = Flexion/Extension LB = Left/Right Lateral Bending

7 PATIENT POPULATION Subsequent Surgeries 2% 18% 15.2% 16% 14% 12% 1% 8% 6% 4% 2% (2/225) (7/225) 4.% (2/15) (2/15) (12/15) % Significantly lower rates of reoperations for patients at all time points (p<.1, Fisher s exact test)

8 Patient Population (%) Adjacent Segment Degeneration 1% 9% 8% 7% 6% 5% 4% 3% 2% 1% % 12 M 24 M 36 M 48 M Statistically significant difference between and treatments at all time points (p<.5, using Mann-Whitney U test to compare the changes of the assessments across the treatments). Patients were classified as having degeneration if there is any worsening by one or more grade in score compared to pre-op. Disc degeneration was graded using the Kellgren-Lawrence scale for grading disc degeneration.

9 Patient Population Patient Satisfaction and Recommendation 1% 9% 8% 7% 6% 5% 4% 3% 2% 1% % Patient Satisfaction Patient Recommendation Statistically significant difference between patients who were very satisfied or would definitely recommend with versus (p<.5, Fisher s exact test).

10 Patient Population Overall Study Success 1% 9% 8% 7% 6% 5% 4% 3% 2% 1% % [ [ [ [ Non-inferiority of over (p<.1), Farrington-Manning test Statistical superiority of over (p<.1), Fisher Exact test

11 Conclusions Early outcomes in higher levels of function, and better NDI and quality of life scores were reported and seen as an advantage for Mobi-C patients compared to patients. At 48 months, Mobi-C at two contiguous levels showed statistical superiority in overall study success, and statistically significant results over in: NDI scores Radiographic evidence of adjacent segment degeneration Rate of subsequent surgeries at index level Patient satisfaction & recommendation The overall study success of Mobi-C through 48 months demonstrates its long term safety and effectiveness as a novel treatment for DDD and possible replacement for.

12 Disclosures Prof. Steib: consultant (Clariance, Depuy, Stryker, Integra) Patent holder (LDR Médical, Clariance, Medtronic, Scient X) Dr. Davis: consultant (LDR Spine), clinical/research support (LDR Spine).