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 |