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From: RETRACTED ARTICLE: Comparison of two FDA-approved interspinous spacers for treatment of lumbar spinal stenosis: Superion versus X-STOP—a meta-analysis from five randomized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