Clinical and Radiological Outcome of a New Total Cervical Disc Replacement Design.
Adult
Cervical Vertebrae
/ diagnostic imaging
Disability Evaluation
Female
Humans
Intervertebral Disc Degeneration
/ complications
Male
Middle Aged
Neck Pain
/ etiology
Ossification, Heterotopic
/ diagnostic imaging
Pain Measurement
Postoperative Complications
/ etiology
Prospective Studies
Prostheses and Implants
/ adverse effects
Prosthesis Design
Radiography
Range of Motion, Articular
Surveys and Questionnaires
Total Disc Replacement
/ instrumentation
Treatment Outcome
Journal
Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646
Informations de publication
Date de publication:
15 02 2019
15 02 2019
Historique:
pubmed:
19
7
2018
medline:
26
7
2019
entrez:
19
7
2018
Statut:
ppublish
Résumé
A nonrandomized, prospective, and single-center clinical trial of the ProDisc Vivo prosthesis. The aim of this study was to investigate the clinical and radiological results of a refined total cervical disc replacement (cTDR), the ProDisc Vivo, with two years of follow-up (FU). The incidence of implant-related complications was recorded as a secondary outcome variable. Previous generations of the ProDisc artificial cervical disc replacement generate high primary stability due to keel-based designs with opening of the anterior cortex during the implantation and subsequent high rates of heterotopic ossifications. Clinical outcome scores included the Neck Disability Index (NDI), Visual Analogue Scale (VAS), arm and neck pain self-assessment questionnaires. The radiological outcome included the range of motion (ROM) and the occurrence of heterotopic ossifications. The incidence of implant-related complications with new implant design was recorded as a secondary outcome variable. A total of 55 patients received a single-level treatment with the ProDisc Vivo cTDR between C3/4 and C6/7, with a follow-up rate of 78%. The clinical outcome scores improved in all parameters significantly (P = 0.0001) (NDI: 68.3 → 17.4; VAS arm: 6.3 → 1.4; VAS neck: 4.9 → 1.6). The ROM of the index-segment did not show a significant change (P = 0.26) (7.9° → 9.2°). Heterotopic ossifications at the index segment was found as grade 0 in 58%, grade 1 in 22%, grade 2 in 10%, grade 3 (with functional impairment of the prosthesis) in 7%, and grade 4 in 3% of the cases. We observed three implant-related complications (5.5%), with two implant dislocations anteriorly and one low-grade infect. cTDR with ProDisc Vivo demonstrated a significant and sustained improvement of all clinical outcome parameters. A less invasive implantation mechanism with lower primary stability of the cTDR might be a reason for a higher dislocation rate than the keel-based previous generation ProDisc C. 4.
Sections du résumé
STUDY DESIGN
A nonrandomized, prospective, and single-center clinical trial of the ProDisc Vivo prosthesis.
OBJECTIVE
The aim of this study was to investigate the clinical and radiological results of a refined total cervical disc replacement (cTDR), the ProDisc Vivo, with two years of follow-up (FU). The incidence of implant-related complications was recorded as a secondary outcome variable.
SUMMARY OF BACKGROUND DATA
Previous generations of the ProDisc artificial cervical disc replacement generate high primary stability due to keel-based designs with opening of the anterior cortex during the implantation and subsequent high rates of heterotopic ossifications.
METHODS
Clinical outcome scores included the Neck Disability Index (NDI), Visual Analogue Scale (VAS), arm and neck pain self-assessment questionnaires. The radiological outcome included the range of motion (ROM) and the occurrence of heterotopic ossifications. The incidence of implant-related complications with new implant design was recorded as a secondary outcome variable.
RESULTS
A total of 55 patients received a single-level treatment with the ProDisc Vivo cTDR between C3/4 and C6/7, with a follow-up rate of 78%. The clinical outcome scores improved in all parameters significantly (P = 0.0001) (NDI: 68.3 → 17.4; VAS arm: 6.3 → 1.4; VAS neck: 4.9 → 1.6). The ROM of the index-segment did not show a significant change (P = 0.26) (7.9° → 9.2°). Heterotopic ossifications at the index segment was found as grade 0 in 58%, grade 1 in 22%, grade 2 in 10%, grade 3 (with functional impairment of the prosthesis) in 7%, and grade 4 in 3% of the cases. We observed three implant-related complications (5.5%), with two implant dislocations anteriorly and one low-grade infect.
CONCLUSION
cTDR with ProDisc Vivo demonstrated a significant and sustained improvement of all clinical outcome parameters. A less invasive implantation mechanism with lower primary stability of the cTDR might be a reason for a higher dislocation rate than the keel-based previous generation ProDisc C.
LEVEL OF EVIDENCE
4.
Identifiants
pubmed: 30020276
doi: 10.1097/BRS.0000000000002799
pii: 00007632-201902150-00005
doi:
Types de publication
Journal Article
Langues
eng
Pagination
E202-E210Références
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