rhBMP-2 (Recombinant Human Bone Morphogenetic Protein-2) In real world spine surgery. A phase IV, National, multicentre, retrospective study collecting data from patient medical files in French spinal centres
DiscussionIn years 2011 and 2012 when the surgeries captured in this retrospective study were done, rhBMP-2 was indicated for single level (L4–S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with DDD. The most common procedure for the treatment with rhBMP-2 was PLF (off-label use), followed by ALIF (on-label use). The safety findings confirm a predictable and manageable safety profile.Level of evidenceIV.
Abstract OBJECTIVEL5-S1 stand-alone anterior lumbar interbody fusion (ALIF) is a reliable technique to treat symptomatic degenerative disc disease but remains controversial for treatment of isthmic spondylolisthesis. In the present study the authors aimed to identify risk factors of instrumentation failure and pseudarthrosis after stand-alone L5-S1 ALIF and to evaluate whether instrumentation failure influenced the rate of fusion.METHODSThe study included 64 patients (22 [34.4%] male and 42 [65.6%] female, mean age 46.4 years [range 21-65 years]) undergoing stand-alone L5-S1 ALIF using radiolucent anterior cages w...
Conditions: Spinal Fusion; Spinal Stenosis; Spondylolisthesis Interventions: Drug: with U-VANCO (vancomycin hydrochloride); Drug: without U-VANCO (vancomycin hydrochloride) Sponsor: Taipei Veterans General Hospital, Taiwan Recruiting
ConclusionsEnhanced strut porosity SiCaP EP provided high (month 12: 86.3%) spinal fusion success rates in PLF surgery. Fusion success was associated with improved clinical outcomes in patients within 12 months, relative to baseline.ClinicalTrials.gov identifierNCT01452022Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.
Conditions: Degenerative Disc Disease; Spondylolisthesis Intervention: Device: NB1 Sponsor: Bone Biologics Corp Not yet recruiting