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Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters
- Source :
- The Spine Journal. 18:S196
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
Abstract
- BACKGROUND CONTEXT Cervical disc replacement today is a very viable option in the management of degenerative disc disease. This 5-year prospective randomised controlled trial compared the combined (single & multilevel), clinical outcomes between NunecTM and Prestige. PURPOSE Our study hypothesis was that the clinical outcomes following anterior cervical decompression disc replacement using NunecTM (PEEK on PEEK) prosthesis is better than or same as Prestige (METAL on METAL) replacement at short to long term follow-up (6 months, 1, 2, 3, 4, and 5 years) STUDY DESIGN/SETTING Prospective Randomised Controlled Trial. PATIENT SAMPLE A total of 57 participants (NunecTM 28; Prestige® 29) were recruited after screening through a rigorous inclusion and exclusion criteriae. OUTCOME MEASURES Primary Outcome measures included (1) Visual Analogue score for Neck pain (VAS-NP) (2) Visual Analogue score for Arm pain (VAS-AP) (3) Neck Disability Index (NDI) (4) Depression and (5) Anxiety scores. Secondary outcome measures as evaluated in the follow-up clinics, included (1) return to work (2) clinical range of movement (3) adjacent segment re-operation (4) complications and (5) implant failure. METHODS Paired t-test was used to analyse any statistical difference between pre and postoperative scores and an unpaired t-test was used to compare the outcome scores between NunecTM and Prestige. RESULTS The mean duration of symptoms for NunecTM was 44.0 months (0–204; SD=52.1) and for Prestige 43.8 months (0–350; SD=78.3). The mean follow-up for NunecTM was 4.86years (2–6 years; SD=0.89) and for Prestige 4.52years (1–6 years; SD=1.18).Apart from NDI for NunecTM, comparison between pre and post-op outcome scores showed a statistically significant improvement (p .05). VAS-NP: CI=−2.27 to 1.27, P=.5733; VAS-AP: CI=−2.46 to 1.50, P=.6303; NDI: CI=−2.55 to 22.2, P=.1170; Anxiety: CI=−2.15 to 3.00, P=.7399; Depression: CI=−2.10 to 3.18, P=.6826. CONCLUSIONS This study validates our hypothesis that the clinical outcomes following anterior cervical decompression disc replacement using NunecTM is the same as Prestige (METAL on METAL) replacement at short to long-term follow-up. There is no tangible advantage in the choice between these two devices. However, there is a statistically significant improvement between the pre and postoperative clinical outcomes for both the devices
- Subjects :
- Neck pain
medicine.medical_specialty
business.industry
medicine.medical_treatment
Implant failure
Context (language use)
medicine.disease
Prosthesis
law.invention
Degenerative disc disease
Randomized controlled trial
law
medicine
Physical therapy
Anxiety
Surgery
Orthopedics and Sports Medicine
Neurology (clinical)
medicine.symptom
business
Depression (differential diagnoses)
Subjects
Details
- ISSN :
- 15299430
- Volume :
- 18
- Database :
- OpenAIRE
- Journal :
- The Spine Journal
- Accession number :
- edsair.doi...........fcdea712c21d6a00a7066fc980dbf722
- Full Text :
- https://doi.org/10.1016/j.spinee.2018.06.657