PMID- 29652784
OWN - NLM
STAT- MEDLINE
DCOM- 20181114
LR  - 20210115
IS  - 1528-1159 (Electronic)
IS  - 0362-2436 (Linking)
VI  - 43
IP  - 15
DP  - 2018 Aug 1
TI  - A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium 
      Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar 
      Fusion for Degenerative Spinal Disorders.
PG  - E860-E868
LID - 10.1097/BRS.0000000000002678 [doi]
AB  - STUDY DESIGN: A prospective, Phase IV, multicenter, randomized study. OBJECTIVE: 
      The aim of this study was to compare vertebral fusion success rates following 
      posterolateral fusion [(PLF)/posterolateral intertransverse fusion (PITF)] 
      surgery. The surgical procedure combined posterior lumbar interbody fusion (PLIF) 
      and PLF with internal fixation over one or two levels using silicated calcium 
      phosphate (SiCaP) or bone morphogenetic protein (BMP)-2 as graft material in 
      patients with a degenerative disorder of the lumbar spine. SUMMARY OF BACKGROUND 
      DATA: Few controlled trials have evaluated the bone graft materials available to 
      surgeons treating patients with spinal disorders, including degenerative disc 
      disease, spondylolisthesis, and disc herniation. METHODS: Following 
      randomization, the surgical procedure consisting of PLIF and PLF with internal 
      fixation over one or two levels was performed using SiCaP or BMP-2. No other 
      osteoconductive/osteoinductive graft materials were permitted. Spinal fusion was 
      assessed radiographically at </=24 months. Clinical outcomes (pain on visual analog 
      scale, Oswestry Disability Index, SF-36) and adverse events (AEs) were monitored. 
      RESULTS: One hundred three patients were enrolled. At 12 months, fusion was 
      achieved in 25 of 35 (71.4%) of the SiCaP and 20 of 27 (74.1%) of the BMP-2 
      group, respectively (P = 1.000). At 24 months, the fusion rate was 78.6% and 
      84.8% for SiCaP and BMP-2, respectively (P = 0.5613). Clinical outcomes improved 
      similarly in both groups over time. AEs were consistent with this surgical 
      population. CONCLUSION: SiCaP was safe and well tolerated in patients with 
      degenerative spinal disorders requiring PLF and provided fusion rates similar to 
      BMP-2. LEVEL OF EVIDENCE: 2.
FAU - Coughlan, Marc
AU  - Coughlan M
AD  - Prince of Wales Private Hospital, Randwick, New South Wales, Australia.
FAU - Davies, Mark
AU  - Davies M
AD  - St. George Medical Centre, Kogarah, New South Wales, Australia.
FAU - Mostert, Adriaan K
AU  - Mostert AK
AD  - Isala Kliniek, Zwolle, the Netherlands.
FAU - Nanda, Dharmin
AU  - Nanda D
AD  - Neurochirurgisch Centrum, Zwolle, Netherlands.
FAU - Willems, Paul C
AU  - Willems PC
AD  - Maastricht University Medical Centre, Maastricht, The Netherlands.
FAU - Rosenberg, Geoffrey
AU  - Rosenberg G
AD  - St. George Private Medical Centre, Kogarah, New South Wales, Australia.
FAU - Ferch, Richard
AU  - Ferch R
AD  - John Hunter Hospital, New Lambton, New South Wales, Australia.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Spine (Phila Pa 1976)
JT  - Spine
JID - 7610646
RN  - 0 (BMP2 protein, human)
RN  - 0 (Bone Morphogenetic Protein 2)
RN  - 0 (Calcium Phosphates)
RN  - 97Z1WI3NDX (calcium phosphate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Bone Morphogenetic Protein 2/*therapeutic use
MH  - Bone Transplantation/*methods
MH  - Calcium Phosphates/*therapeutic use
MH  - Female
MH  - Humans
MH  - Lumbar Vertebrae/diagnostic imaging/surgery
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Spinal Diseases/diagnostic imaging/*surgery
MH  - Spinal Fusion/*methods
MH  - Treatment Outcome
EDAT- 2018/04/14 06:00
MHDA- 2018/11/15 06:00
CRDT- 2018/04/14 06:00
PHST- 2018/04/14 06:00 [pubmed]
PHST- 2018/11/15 06:00 [medline]
PHST- 2018/04/14 06:00 [entrez]
AID - 00007632-201808010-00002 [pii]
AID - 10.1097/BRS.0000000000002678 [doi]
PST - ppublish
SO  - Spine (Phila Pa 1976). 2018 Aug 1;43(15):E860-E868. doi: 
      10.1097/BRS.0000000000002678.