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Table 1 Characteristics of included studies

From: RETRACTED ARTICLE: Comparison of two FDA-approved interspinous spacers for treatment of lumbar spinal stenosis: Superion versus X-STOP—a meta-analysis from five randomized controlled trial studies

First author and year Study design Region Details Intervention Follow-up (months) Outcomes
Miller LE et al. [13] 2012 Multicenter randomized controlled trial USA n = 166
Superion: 80
X-STOP: 86
Mean age
Superion: 67 ± 9 year
X-STOP: 67 ± 11 year
Gender
Superion: 48 males, 32 females
X-STOP: 57 males, 29 females
Prosthetic type
Superion interspinous spacer system (Vertiflex, Inc., San Clemente, CA, USA)
X-STOP interspinous process decompression system (Medtronic, Inc., Sunnyvale, CA, USA)
Disease
Patients with mild to moderate neurogenic intermittent claudication
secondary to LSS
24 1.2.3.4.5.6
Whang PG et al. [14] 2013 Prospective multicenter randomized controlled trial USA n = 166
Superion: 75
X-STOP: 70
Mean age
Superion: NP
X-STOP: NP
Gender
Superion: NP
X-STOP: NP
Prosthetic type
Superion interspinous spacer system (Vertiflex, Inc., San
Clemente, CA, USA)
X-STOP interspinous process decompression system (Medtronic, Inc., Memphis, CA, USA)
Disease
Patients with moderate neurogenic intermittent claudication secondary to LSS
18 1.2.3.4
Haley T et al. [15] 2013 Prospective randomized controlled
FDA IDE trials
USA n = 145
Superion: 75
X-STOP: 70
Mean age
Superion: NP
X-STOP: NP
Gender
Superion: NP
X-STOP: NP
Prosthetic type
Superion interspinous spacer system (Vertiflex, Inc., San
Clemente, CA, USA)
X-STOP interspinous process decompression system (Medtronic, Inc., Memphis, CA, USA)
Disease
Patients with intermittent claudication secondary to LSS
18 1.2.3.4.6
Patel VV et al. [8] 2015 Prospective multicenter randomized controlled trial USA n = 250
Superion: 123
X-STOP: 127
Mean age
67 years
Gender
150 males, 100 females
Prosthetic type
Superion interspinous spacer system (Vertiflex, Inc., San
Clemente, CA, USA)
X-STOP interspinous process decompression system (Medtronic, Inc., Sunnyvale, CA, USA)
Disease
Patients with moderate neurogenic intermittent claudication
secondary to LSS
24 2.3.4.5.6
Blumenthal SL et al. [16] 2014 Prospective multicenter randomized controlled trial USA n = 391
Superion: 190
X-STOP: 201
Mean age
Superion: NP
X-STOP: NP
Gender
Superion: NP
X-STOP: NP
Prosthetic type
Superion interspinous spacer system (Vertiflex, Inc., San
Clemente, CA, USA)
X-STOP interspinous process decompression system (Medtronic, Inc., Sunnyvale, CA, USA)
Disease
Patients with moderate neurogenic intermittent claudication
secondary to LSS
24 5
  1. Note: 1 ZCQ patient satisfaction score, 2 axial pain severity, 3 extremity pain severity, 4 back-specific functional impairment, 5 reoperation, 6 complication