PMID- 28544495
OWN - NLM
STAT- MEDLINE
DCOM- 20180417
LR  - 20200225
IS  - 1757-7861 (Electronic)
IS  - 1757-7853 (Print)
IS  - 1757-7853 (Linking)
VI  - 9
IP  - 2
DP  - 2017 May
TI  - Posterior Lumbar Interbody Fusion with Interspinous Fastener Provides Comparable 
      Clinical Outcome and Fusion Rate to Pedicle Screws.
PG  - 198-205
LID - 10.1111/os.12328 [doi]
AB  - OBJECTIVE: To investigate the clinical feasibility and validity of interspinous 
      fastener (ISF) for lumbar degenerative diseases. METHODS: From October 2013 to 
      March 2014, a total of 46 patients suffering from lumbar degenerative diseases 
      underwent posterior lumbar interbody fusion (PLIF) randomly augmented by ISF or 
      pedicle screws. The clinical outcome was primarily measured by Oswestry 
      Disability Index (ODI) score. The minimal clinical important difference (MCID) 
      was defined as an eight-point decrease in ODI. The second clinical outcome 
      measurement was Japanese Orthopedic Association (JOA) score. Interbody fusion 
      rates were evaluated by lumbar plain radiograph and computed tomography (CT) 
      scan. Complications were also compared between groups. Statistical analyses were 
      performed by SPSS version 13.0. Sample size calculation was performed before the 
      study. The type I error alpha was set at 0.05 and the type II error beta at 0.1. Based 
      on these assumptions and adding 10% for possible drop-outs, sample size 
      calculations indicated that a total of 46 patients were required for the study. 
      Parametric data was compared by independent t-test and categorical variables were 
      compared using chi(2) -tests or Fisher exact tests depending on the sample size. A 
      P-value of less than 0.05 was considered significantly statistically different. 
      Fleiss kappa coefficients were calculated for intra-observer and inter-observer 
      reliability. RESULTS: A total of 43 patients completed the follow-up, with 22 
      cases in the ISF group and 21 patients in the pedicle screws group, respectively. 
      Less intraoperative blood loss and shorter operation time were observed in the 
      ISF group. The mean ODI significantly declined in both groups, with the ISF 
      group's decreasing from preoperative 43.3 +/- 8.2 to 21.4 +/- 3.5 at 24-month 
      follow-up and the pedicle screws group's decreasing from preoperative 42.9 +/- 7.9 
      to 22.5 +/-3.8 at 24-month follow-up, respectively. The ODI changes between groups 
      had no statistical difference (P > 0.05). Of the 43 patients, 33 patients 
      achieved an MCID. The bone fusion rate was 77.3% according to X-rays and 68.2% 
      according to CT scans in the ISF group, and 81.0% according to X-rays and 76.2% 
      according to CT scans in the pedicle screws group at the final follow-up. The 
      intra-observer and inter-observer reliability assessed by the kappa value were 
      0.93 and 0.89, respectively. One patient in the pedicle screws group demonstrated 
      screw loosening at the 6-month follow-up but was asymptomatic. One patient with 
      spondylolisthesis in the ISF group demonstrated cage subsidence during the 
      follow-up but also without related symptoms. CONCLUSION: The less invasive ISF 
      combined with PLIF provided comparable clinical outcome and a similar bone fusion 
      rate to pedicle screws. The ISF could potentially serve as a new alternative for 
      lumbar degenerative diseases.
CI  - (c) 2017 Chinese Orthopaedic Association and John Wiley & Sons Australia, Ltd.
FAU - Huang, Wei-Min
AU  - Huang WM
AD  - Department of Orthopaedics, General Hospital of Jinan Military Commanding Region, 
      Jinan, China.
FAU - Yu, Xing-Ming
AU  - Yu XM
AD  - Postgraduate Training Base in General Hospital of Jinan Military Command, 
      Liaoning Medical University, Jinzhou, China.
FAU - Xu, Xiao-Duo
AU  - Xu XD
AD  - Department of Orthopaedics, General Hospital of Jinan Military Commanding Region, 
      Jinan, China.
FAU - Song, Ruo-Xian
AU  - Song RX
AD  - Department of Orthopaedics, General Hospital of Jinan Military Commanding Region, 
      Jinan, China.
FAU - Yu, Li-Li
AU  - Yu LL
AD  - Department of Statistics, General Hospital of Jinan Military Commanding Region, 
      Jinan, China.
FAU - Yu, Xiu-Chun
AU  - Yu XC
AD  - Department of Orthopaedics, General Hospital of Jinan Military Commanding Region, 
      Jinan, China.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170524
PL  - Australia
TA  - Orthop Surg
JT  - Orthopaedic surgery
JID - 101501666
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Loss, Surgical
MH  - Female
MH  - Humans
MH  - Intervertebral Disc Degeneration/*surgery
MH  - Lumbar Vertebrae/*surgery
MH  - Magnetic Resonance Imaging
MH  - Male
MH  - Middle Aged
MH  - Observer Variation
MH  - Operative Time
MH  - *Pedicle Screws
MH  - Prostheses and Implants
MH  - Spinal Fusion/*instrumentation
MH  - Tomography, X-Ray Computed
MH  - Treatment Outcome
PMC - PMC6584360
OTO - NOTNLM
OT  - Fusion rate
OT  - Interspinous fastener
OT  - Lumbar degenerative diseases
OT  - Pedicle screws
EDAT- 2017/05/26 06:00
MHDA- 2018/04/18 06:00
PMCR- 2017/05/24
CRDT- 2017/05/26 06:00
PHST- 2016/09/17 00:00 [received]
PHST- 2017/02/16 00:00 [accepted]
PHST- 2017/05/26 06:00 [pubmed]
PHST- 2018/04/18 06:00 [medline]
PHST- 2017/05/26 06:00 [entrez]
PHST- 2017/05/24 00:00 [pmc-release]
AID - OS12328 [pii]
AID - 10.1111/os.12328 [doi]
PST - ppublish
SO  - Orthop Surg. 2017 May;9(2):198-205. doi: 10.1111/os.12328. Epub 2017 May 24.