PMID- 26961193
OWN - NLM
STAT- MEDLINE
DCOM- 20171211
LR  - 20190318
IS  - 1432-5195 (Electronic)
IS  - 0341-2695 (Linking)
VI  - 40
IP  - 6
DP  - 2016 Jun
TI  - Bone morphogenetic protein use in spine surgery-complications and outcomes: a 
      systematic review.
PG  - 1309-19
LID - 10.1007/s00264-016-3149-8 [doi]
AB  - PURPOSE: Because of significant complications related to the use of autologous 
      bone grafts in spinal fusion surgery, bone substitutes and growth factors such as 
      bone morphogenetic protein (BMP) have been developed. One of them, recombinant 
      human (rh) BMP-2, has been approved by the Food and Drug Administration (FDA) for 
      use under precise conditions. However, rhBMP-2-related side effects have been 
      reported, used in FDA-approved procedures, but also in off-label use.A systematic 
      review of clinical data was conducted to analyse the rhBMP-2-related adverse 
      events (AEs), in order to assess their prevalence and the associated surgery 
      practices. METHODS: Medline search with keywords "bone morphogenetic protein 2", 
      "lumbar spine", "anterolateral interbody fusion" (ALIF) and the filter "clinical 
      trial". FDA published reports were also included. Study assessment was made by 
      authors (experienced spine surgeons), based on quality of study designs and level 
      of evidence. RESULTS: Extensive review of randomised controlled trials (RCTs) and 
      controlled series published up to the present point, reveal no evidence of a 
      significant increase of AEs related to rhBMP-2 use during ALIF surgeries, 
      provided that it is used following FDA guidelines. Two additional RCTs performed 
      with rhBMP-2 in combination with allogenic bone dowels reported increased bone 
      remodelling in BMP-treated patients. This AE was transient and had no consequence 
      on the clinical outcome of the patients. No other BMP-related AEs were reported 
      in these studies. CONCLUSIONS: This literature review confirms that the use of 
      rhBMP-2 following FDA-approved recommendations (i.e. one-level ALIF surgery with 
      an LT-cage) is safe. The rate of complications is low and the AEs had been 
      identified by the FDA during the pre-marketing clinical trials. The clinical 
      efficiency of rhBMP-2 is equal or superior to that of allogenic or autologous 
      bone graft in respect to fusion rate, low back pain disability, patient 
      satisfaction and rate of re-operations. For all other off-label use, the safety 
      and effectiveness of rhBMP-2 have not been established, and further RCTs with 
      high level of evidence are required.
FAU - Faundez, Antonio
AU  - Faundez A
AD  - Hopital Universitaire de Geneve, Rue Gabrielle Perret-Gentil 4, 1211, Geneva 14, 
      Switzerland.
FAU - Tournier, Clement
AU  - Tournier C
AD  - Universite Bordeaux, Orthospine Department 2, 146 rue Leo Saignat, 33076, 
      Bordeaux Cedex, France.
FAU - Garcia, Matthieu
AU  - Garcia M
AD  - Universite Bordeaux, Orthospine Department 2, 146 rue Leo Saignat, 33076, 
      Bordeaux Cedex, France.
FAU - Aunoble, Stephane
AU  - Aunoble S
AD  - Universite Bordeaux, Orthospine Department 2, 146 rue Leo Saignat, 33076, 
      Bordeaux Cedex, France.
FAU - Le Huec, Jean-Charles
AU  - Le Huec JC
AD  - Universite Bordeaux, Orthospine Department 2, 146 rue Leo Saignat, 33076, 
      Bordeaux Cedex, France. j-c.lehuec@u-bordeaux2.fr.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20160310
PL  - Germany
TA  - Int Orthop
JT  - International orthopaedics
JID - 7705431
RN  - 0 (Bone Morphogenetic Protein 2)
RN  - 0 (Recombinant Proteins)
RN  - 0 (Transforming Growth Factor beta)
RN  - 0 (recombinant human bone morphogenetic protein-2)
SB  - IM
MH  - Adult
MH  - Bone Morphogenetic Protein 2/*adverse effects/therapeutic use
MH  - Bone Transplantation/*adverse effects/methods
MH  - Female
MH  - Humans
MH  - Low Back Pain/etiology
MH  - Lumbar Vertebrae/*surgery
MH  - Male
MH  - Middle Aged
MH  - Off-Label Use
MH  - Postoperative Complications/epidemiology
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Spinal Fusion/adverse effects/*methods
MH  - Transforming Growth Factor beta/*adverse effects/therapeutic use
OTO - NOTNLM
OT  - *Adverse effects
OT  - *Bone morphogenetic protein
OT  - *Osteoinduction
OT  - *Spinal fusion
EDAT- 2016/03/11 06:00
MHDA- 2017/12/12 06:00
CRDT- 2016/03/11 06:00
PHST- 2015/09/18 00:00 [received]
PHST- 2016/02/25 00:00 [accepted]
PHST- 2016/03/11 06:00 [entrez]
PHST- 2016/03/11 06:00 [pubmed]
PHST- 2017/12/12 06:00 [medline]
AID - 10.1007/s00264-016-3149-8 [pii]
AID - 10.1007/s00264-016-3149-8 [doi]
PST - ppublish
SO  - Int Orthop. 2016 Jun;40(6):1309-19. doi: 10.1007/s00264-016-3149-8. Epub 2016 Mar 
      10.