PMID- 31807089
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220411
IS  - 1179-1462 (Electronic)
IS  - 1179-1462 (Linking)
VI  - 11
DP  - 2019
TI  - Does Patient Blinding Influence Clinical Outcomes After Annular Closure Device 
      Implantation? A Propensity Score-Matched Analysis.
PG  - 177-182
LID - 10.2147/ORR.S216980 [doi]
AB  - BACKGROUND: Awareness of treatment group assignment in a clinical trial may 
      influence patient behavior and bias outcome reporting. The objective of this 
      study was to compare 2-year clinical outcomes in blinded vs unblinded patients 
      who were treated with lumbar discectomy and a bone-anchored annular closure 
      device (ACD) for prevention of lumbar disc reherniation. METHODS: This was a 
      secondary analysis of a randomized trial comparing lumbar discectomy with (n=272) 
      vs without (n=278) implantation of a bone-anchored ACD. Among patients who 
      received ACD implantation, 35 (13%) were blinded and 237 (87%) were unblinded to 
      treatment allocation. In patients treated with ACD, propensity score-matching 
      (1:1) was performed to account for imbalances in patient characteristics between 
      blinded and unblinded groups. Key clinical outcomes were back pain severity 
      (0-100 scale), leg pain severity (0-100 scale), Oswestry Disability Index (ODI, 
      0-100 scale), symptomatic reherniation, reoperation at the treated lumbar level, 
      and device- or procedure-related serious adverse events (AEs). Outcomes were 
      reported through 2 years of follow-up, which coincided with the time at which 
      blinded patients were unblinded. RESULTS: There were no statistically significant 
      differences in 2-year outcomes between propensity score-matched blinded (n=35) 
      and unblinded (n=35) patients treated with the ACD. In blinded vs unblinded ACD 
      patients compared to baseline, back pain severity decreased by 40 vs 37 points 
      (P=0.61), leg pain severity decreased by 75 points in each group (P>0.99), and 
      ODI decreased by 47 vs 43 points (P=0.19). The risks of symptomatic reherniation 
      (5.7% vs 9.1%; P=0.59), reoperation (8.6% vs 12.2%, P=0.62), and device- or 
      procedure-related serious AEs (5.7% vs 8.9%, P=0.63) were comparably low in 
      blinded and unblinded patients. CONCLUSION: In patients treated with lumbar 
      discectomy and a bone-anchored ACD, there were no clinically important or 
      statistically significant differences in back pain, leg pain, ODI, symptomatic 
      reherniation, reoperation, or serious AEs over 2 years of follow-up when 
      comparing patients who were blinded vs unblinded to their treatment assignment. 
      The main limitations of this study were the post hoc nature of the analysis and 
      the potential for bias due to surgeon awareness of treatment assignment.
CI  - (c) 2019 Bouma et al.
FAU - Bouma, Gerrit J
AU  - Bouma GJ
AUID- ORCID: 0000-0002-2772-7475
AD  - Department of Neurosurgery, OLVG and Amsterdam University Medical Centers, 
      Amsterdam, The Netherlands.
FAU - van den Brink, Wimar
AU  - van den Brink W
AUID- ORCID: 0000-0002-4588-2209
AD  - Neurochirurgisch Centrum Zwolle, Zwolle, The Netherlands.
FAU - Miller, Larry E
AU  - Miller LE
AUID- ORCID: 0000-0003-1594-1885
AD  - Miller Scientific Consulting, Asheville, NC, USA.
FAU - Wolfs, Jasper Fc
AU  - Wolfs JF
AD  - Haaglanden Medical Center Westeinde Antoniushove, Leidschendam, The Netherlands.
FAU - Arts, Mark P
AU  - Arts MP
AD  - Department of Neurosurgery, Haaglanden Medical Center Westeinde, The Hague, The 
      Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20191108
PL  - New Zealand
TA  - Orthop Res Rev
JT  - Orthopedic research and reviews
JID - 101531415
PMC - PMC6850684
OTO - NOTNLM
OT  - annulus fibrosus
OT  - blinding
OT  - disc
OT  - discectomy
OT  - elderly
OT  - herniation
OT  - lumbar
OT  - sciatica
COIS- Gerrit Bouma reports grants from Intrinsic Therapeutics, during the conduct of 
      the study. Wimar van den Brink reports financial support for study conductance 
      from Intrinsic Therapeutics. Larry Miller reports consultancy with Intrinsic 
      Therapeutics. Jasper Wolfs reports nonfinancial support from Intrinsic 
      Therapeutics; Consultancy activities Training and education from Zimmer Biomet, 
      Safe Orthopaedics, Silony, and has a patent with EIT GMBH with royalties paid, 
      outside the submitted work. Mart Arts reports consultancy with Intrinsic 
      Therapeutics, Zimmer Biomet, EIT, Baxter and Silony, outside the submitted work, 
      and has a patent with EIT GMBH with royalties paid. The authors report no other 
      conflicts of interest in this work.
EDAT- 2019/12/07 06:00
MHDA- 2019/12/07 06:01
PMCR- 2019/11/08
CRDT- 2019/12/07 06:00
PHST- 2019/05/24 00:00 [received]
PHST- 2019/10/25 00:00 [accepted]
PHST- 2019/12/07 06:00 [entrez]
PHST- 2019/12/07 06:00 [pubmed]
PHST- 2019/12/07 06:01 [medline]
PHST- 2019/11/08 00:00 [pmc-release]
AID - 216980 [pii]
AID - 10.2147/ORR.S216980 [doi]
PST - epublish
SO  - Orthop Res Rev. 2019 Nov 8;11:177-182. doi: 10.2147/ORR.S216980. eCollection 
      2019.