PMID- 34474447
OWN - NLM
STAT- MEDLINE
DCOM- 20211213
LR  - 20231020
IS  - 1528-1159 (Electronic)
IS  - 0362-2436 (Linking)
VI  - 47
IP  - 1
DP  - 2022 Jan 1
TI  - The Clinical Relevance of the Cervical Disc Prosthesis: Combining Clinical 
      Results of Two RCTs.
PG  - 67-75
LID - 10.1097/BRS.0000000000004113 [doi]
AB  - STUDY DESIGN: Retrospective analysis was performed on data from 251 patients that 
      were included in two randomized, double-blinded clinical trials comparing 
      clinical results of anterior cervical discectomy and arthroplasty (ACDA) to 
      anterior cervical discectomy and fusion (ACDF), and anterior cervical discectomy 
      (ACD), for single-level disc herniation. OBJECTIVE: This study aimed to 
      investigate whether the ACDA procedure offers superior clinical results 2 years 
      after surgery, to either ACDF or ACD without instrumentation, in the entire group 
      of patients or in a particular subgroup of patients. SUMMARY OF BACKGROUND DATA: 
      The cervical disc prosthesis was introduced to provide superior clinical outcomes 
      after ACD. METHODS: Neck Disability Index (NDI), and subscales of the 36-item 
      short-form health survey (SF-36) and McGill pain score were collected at 
      baseline, 1 year and 2 years after surgery. Reoperations and complications were 
      also evaluated. A preliminary subgroup analysis was performed for age, disc 
      height, body mass index (BMI), smoking, and sex. RESULTS: The NDI decreased 
      comparably in all treatment arms to circa 50% of the baseline value and marginal 
      mean NDI differences varied from 0.4 to 1.1 on a 100 point NDI scale, with 
      confidence intervals never exceeding the 20-point minimal clinical important 
      difference (MCID). Secondary outcome parameters showed comparable results. 
      Preliminary subgroup analysis could not demonstrate clinically relevant 
      differences in NDI between treatments after 2 years. CONCLUSION: After combining 
      data from two Randomized Controlled Trials it can be concluded that there is no 
      clinical benefit for ACDA, when compared with ACDF or ACD 2 years after surgery. 
      Preliminary subgroup analysis indicated outcomes were similar between treatment 
      groups, and that no subgroup could be appointed that benefited more from either 
      ACD, ACDF, or ACDA.Level of Evidence: 1.
CI  - Copyright (c) 2021 Wolters Kluwer Health, Inc. All rights reserved.
FAU - Goedmakers, Caroline M W
AU  - Goedmakers CMW
AD  - Department of Neurosurgery, Leiden University Medical Center, Leiden, the 
      Netherlands.
AD  - Computational Neuroscience Outcomes Center (CNOC), Department of Neurosurgery, 
      Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
FAU - Bartels, Ronald H M A
AU  - Bartels RHMA
AD  - Department of Neurosurgery, Radboud University Medical Centre, Nijmegen, The 
      Netherlands.
FAU - Donk, Roland D
AU  - Donk RD
AD  - Department of Orthopaedics, Via Sana Clinics, Nijmegen, the Netherlands.
FAU - Arts, Mark P
AU  - Arts MP
AD  - Department of Neurosurgery, Haaglanden Medical Center, the Hague, the 
      Netherlands.
FAU - van Zwet, Erik W
AU  - van Zwet EW
AD  - Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, 
      the Netherlands.
FAU - Vleggeert-Lankamp, Carmen L A
AU  - Vleggeert-Lankamp CLA
AD  - Department of Neurosurgery, Leiden University Medical Center, Leiden, the 
      Netherlands.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Spine (Phila Pa 1976)
JT  - Spine
JID - 7610646
SB  - IM
CIN - Spine (Phila Pa 1976). 2022 May 1;47(9):E432-E433. PMID: 35533297
MH  - Cervical Vertebrae/surgery
MH  - Diskectomy/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - *Intervertebral Disc Degeneration/surgery
MH  - *Intervertebral Disc Displacement/surgery
MH  - Prostheses and Implants
MH  - Retrospective Studies
MH  - *Spinal Fusion/adverse effects
MH  - *Total Disc Replacement/adverse effects
MH  - Treatment Outcome
EDAT- 2021/09/03 06:00
MHDA- 2021/12/15 06:00
CRDT- 2021/09/02 20:30
PHST- 2021/09/03 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/09/02 20:30 [entrez]
AID - 00007632-202201010-00013 [pii]
AID - 10.1097/BRS.0000000000004113 [doi]
PST - ppublish
SO  - Spine (Phila Pa 1976). 2022 Jan 1;47(1):67-75. doi: 10.1097/BRS.0000000000004113.