#537 ProDisc®-C Nova total disc replacement – 2 year follow up

Oral Posters: Cervical Arthroplasty

Presented by: R. Bertagnoli

Author(s):

R. Bertagnoli (1)

(1) ProSpine, Straubing Bogen, Germany

Abstract

Introduction: Cervical total disc replacement (CTDR) is intended to relief discogenic pain, restore disc height, and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease. The ProDisc®-C Nova (Synthes Gmbh) is the next-generation ProDisc®- C. It has a double keel design on the caudal endplate better suitable for multi-level implantation as well as an updated material composition to allowing better MRI imaging. The purpose of this study was to follow up the preliminary clinical results of the ProDisc®-C Nova TDR.

Methods: Beginning in 2009, a prospective, controlled, consecutive case series of 179 patients have received 362 devices. To date, patients have been assessed pre and post - operatively at 3, 6months and then yearly. Evaluations included the Neck Disability Index (NDI), Visual Analog pain Scales (VAS), SF-36 patient self-assessments, satisfaction and physical and neurological exams, and radiographic evaluation.

Results: 84 males (mean 52 yrs. 26 - 84) and 96 females (mean 52 yrs. 29 - 74yrs.).30.7% were single-level (C3/C4 = 2; C4/C5 = 13; C5/C6 = 22; C6/C7 =16, C7/Th1 =2 ); 44.7% two-level (C3-C5 = 9; C4-C6 = 15; C5-C7 =51 C7-Th1 =1; C3/C4+C5/C7 = 2; C4/C5 +C6/C7 = 2 ); 16.2% three-level (C3-C6= 9; C4-C7 = 17; 3 others not adjacent ) and 8,4% four-level surgery (C3 - C7 = 13; C4 - Th1 = 1; C3/C4+C5-C7+Th1/Th2=1).

At 3 months, the mean NDI score (in %) improved significantly and is maintained out to 24 months (preOP 45.9 ± 20 3 months: 31 ± 20; 6 months 32.5 ± 20.4; 12 months 32 ± 20,1, 24 months 31,5 ± 21). Similarly, the mean VAS score showed significant improvement at 3 months from preOP, and is maintained out to 24 months (preOP: 5,7 ± 2,5 mm; 3 months: 3.7 ± 2.5mm; 6 months: 3,7 ± 2,4; 12 months: 4,0 ± 2.3, 24 months: 3,8 ± 2.7. The SF 36 physical / mental component and total was preOP: P 37.1 ± 8.7 M 25,1 ± 9,9 T 76.6 ± 18,4; 3 months P 42,5 ± 10,7 M 28,4 ± 9,7 T 87,1 ± 18; 6 months P 41,2 ± 10,8 M 27,2 ± 9,9 T 84.7 ± 20,6; at 12 months P 41,4 ± 11,5 M 27,3 ± 9,2 T 85,9 ± 17,8; and 24 months P 40,6 ± 11, 1 M 26,1 ± 7,2 T 90,7 ± 19,0.

At 12 months 90.9 % of patients were very satisfied or satisfied, at 24 month 93 % were very satisfied or satisfied with their surgery. Radiographic evaluation demonstrated that functional range of motion was being maintained. 36 months data is statistically not sufficient yet.

Conclusions: Since the majority of the affected patients require multi-level surgery, the design of the ProDisc®-C Nova is optimal for these cases, and allows for superior imaging. These results of this study provide evidence that ProDisc®-C Nova is a safe and efficacious TDR surgical treatment for patients with disabling disc disease in both single and multi cervical vertebral levels. Longer follow up is required to confirm these findings.

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