N/A
Completed N=194
PRESTIGE Observational Study
Degenerative Cervical Disc Disease
Source: ClinicalTrials.gov NCT00875810 ↗
Enrolled (actual)
194
Serious AEs
3.7%
Results posted
Mar 2015
Primary outcomePrimary: EQ-5D — 0.59; 0.78; 0.77; 0.80 units on a scale
Summary
Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence.
The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EQ-5D |
0.59; 0.78; 0.77; 0.80; 0.76 | — |
| PRIMARY Neck Disability Index (NDI) Score |
24.1; 13.2; 12.6; 12.3; 13.4 | — |
| SECONDARY Duration of Pain Prior to Enrollment |
22.1; 21.3; 37.4 | — |
| SECONDARY Intervertebral Disc Space |
0.22; 0.41; 0.42; 0.40; 0.39 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must be willing to sign a Patient Data Release Form.
- Patient with degenerative disc disease (DDD) who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.
Exclusion Criteria
- Patient fulfills any contraindication according to the product description.
- Patient has not reached the age of legal consent according to local laws.
- Patient has diabetes.
- Patient has Body Mass Index (BMI) > 35.
- Patient has affected disc not between C3/C4 and C6/C7.
- Patient with instability of cervical spine.
- Patients who will receive extensive decompression.
Data sourced from ClinicalTrials.gov (NCT00875810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.