142 - Randomized Control Trial Comparing Prestige and Nunec Cervical Disc Ar...

#142 Randomized Control Trial Comparing Prestige and Nunec Cervical Disc Arthroplasty

Oral Posters: Cervical Arthroplasty

Presented by: P. Karpe

Author(s):

P. Karpe (1)
B. Purushothaman (1)
A. Berg (1)
G. Reddy (1)
C. Bhatia (1)
T. Friesem (1)

(1) North Tees and Hartlepool NHS Trust, Orthopaedics, Stockton, United Kingdom

Abstract

Objective: To report early functional outcomes on prospectively randomized patients to either the Prestige or Nunec cervical disc prosthesis at a single site.

Summary of Background Data: Anterior cervical disc replacement (CDR) is a well-established option to arthrodesis to treat degenerative disc disease.

The PRESTIGE® Cervical Disc consisting of stainless steel in a ball-and-trough configuration is the first artificial disc to be approved by the U.S. FDA for use in the cervical spine. On the other hand NUNEC Cervical disc with on going trials for FDA approval speaks about self-mating PEEK as an alternative material with added advantage of being radiolucent and more MRI compatible.

No studies in past have compared the clinical outcomes in patients having either one of these two disc replacements.

Material and Methods: In this prospective, single blinded study, from October 2010 to June 2012,42 patients (Mean age 48.37, 32-67) with symptomatic cervical disc degeneration (radiculopathy and/or myelopathy) were randomly assigned to 1 of 2 treatment groups. The results of one group, in which patients received the Prestige disc prosthesis, were compared to the other group who underwent Nunec disc prosthesis. Cervical neutral and flexion -extension radiographs were obtained preoperatively and at each follow up after surgery. Clinical outcomes were assessed using VAS, NDI and SF36 (Bodily pain) were registered preoperatively and at regular follow up postoperatively. Secondary outcome measures were hospital anxiety, depression scores and neurological status.

Average duration of symptoms was 56 months (6-24 months). Mean follow-up was 7.88 months [2-15].

Results: All 42 patients had primary surgeries with 86 operated levels. 21 patients underwent Prestige disc arthroplasty while the rest 21 had Nunec disc arthroplasty.

Levels of surgery included between C3-C7, the most common being C56

There were no implant related problems till date.

There was statistically significant improvement in clinical outcomes when comparing pre and postop scores. The mean NDI difference was 16.66 (p=0.03). The VAS (Neck) mean difference was 4.22, (p< 0.01). The VAS (Arm) mean difference was 2.66 (p < 0.05). The mean SF36 difference was 5.82 (p =0.11).

When the Nunec group was compared with the Prestige, we observed no statistically significant difference in clinical outcomes in NDI, SF 36 (Bodily pain), VAS (arm and neck) (p>0.05).

Conclusions: Cervical disc replacement has produced both clinically and statistically significant improvement in functional outcome. The choice of the implant (Nunec vs. Prestige) did not affect the outcome and the midterm results were comparable between the two groups.