A Systematic Review of Lumbar Fusion Rates with and Without the Use of rhBMP-2

Fabrizio Galimberti, Daniel Lubelski, Andrew T. Healy, Timothy Wang, Kalil G. Abdullah, Amy S. Nowacki, Edward C. Benzel, Thomas E. Mroz

Research output: Contribution to journalReview article

25 Citations (Scopus)

Abstract

Study Design. Systematic review. Objective. To evaluate literature comparing fusion rates in anterior lumbar interbody fusion (ALIF), posterior lumbar interbody/transforaminal lumbar interbody fusion (PLIF/TLIF), and posterolateral lumbar fusion (PLF) with and without recombinant human bone morphogenetic protein-2 (rhBMP-2). Summary of Background Data. rhBMP-2 is used for the FDA-approved indication of single-level ALIF with LT-Cage and off-label for PLIF/TLIF, and PLF. Due to recent controversies, it is essential to evaluate the literature for its effects on fusion rates to evaluate whether benefits outweigh potential complications. Methods. A Medline search was performed of clinical studies published between May 2000 and May 2012 comparing fusion rates after ALIF, PLIF/TLIF, and PLF surgery with versus without rhBMP-2. Only studies with a control arm were reviewed. Results. 16 studies were reviewed (1794 patients, 995 treated with rhBMP-2 and 799 without). 5 of 5 studies for PLIF/TLIF (including 301 of 301 patients), 1 of 4 for ALIF (including 279 of 589 patients), and 3 of 7 for PLF (including 272 of 904 patients) reported no significant improvement in fusion rates with rhBMP-2 compared with those without rhBMP-2 at longest follow-up investigated. Average fusion rate 24 months after surgery was 97.8% for ALIF (n = 316), 95.7% for PLIF/TLIF (n = 141), and 93.6% for PLF (n = 422) with rhBMP-2 and 88.2% (n = 228), 89.5% (n = 86), and 83.1% (n = 372) without rhBMP-2, for ALIF, PLIF/TLIF, and PLF, respectively. Odds ratio of fusion were calculated as 7.08 (95% CI: 1.54-32.7) in ALIF, 1.98 (95% CI: 0.39-10.1) in PLIF/TLIF, and 3.06 (95% CI: 1.61-5.80) in PLF with rhBMP-2 as compared with without rhBMP-2. Conclusion. Although numerous studies did not show statistically significant improvement in fusion rates with rhBMP-2 use, analysis of combined studies revealed significant improvement in fusion rate with rhBMP-2 in ALIF and PLF patients. Notably, even when pooling data from several studies, rhBMP-2 did not result in statistically significantly improved fusion rates in PLIF/TLIF. However, heterogeneity of rhBMP-2 dosing, surgical techniques, and quality of papers reviewed may limit the validity of conclusions drawn.

Original languageEnglish (US)
Pages (from-to)1132-1139
Number of pages8
JournalSpine
Volume40
Issue number14
DOIs
StatePublished - Jul 15 2015
Externally publishedYes

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recombinant human bone morphogenetic protein-2
Meta-Analysis
Odds Ratio
Clinical Studies

Keywords

  • anterior lumbar interbody fusion
  • fusion rate
  • lumbar fusion
  • posterior lumbar interbody fusion
  • posterolateral lumbar fusion
  • recombinant human bone morphogenetic protein-2

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Clinical Neurology

Cite this

Galimberti, F., Lubelski, D., Healy, A. T., Wang, T., Abdullah, K. G., Nowacki, A. S., ... Mroz, T. E. (2015). A Systematic Review of Lumbar Fusion Rates with and Without the Use of rhBMP-2. Spine, 40(14), 1132-1139. https://doi.org/10.1097/BRS.0000000000000971

A Systematic Review of Lumbar Fusion Rates with and Without the Use of rhBMP-2. / Galimberti, Fabrizio; Lubelski, Daniel; Healy, Andrew T.; Wang, Timothy; Abdullah, Kalil G.; Nowacki, Amy S.; Benzel, Edward C.; Mroz, Thomas E.

In: Spine, Vol. 40, No. 14, 15.07.2015, p. 1132-1139.

Research output: Contribution to journalReview article

Galimberti, F, Lubelski, D, Healy, AT, Wang, T, Abdullah, KG, Nowacki, AS, Benzel, EC & Mroz, TE 2015, 'A Systematic Review of Lumbar Fusion Rates with and Without the Use of rhBMP-2', Spine, vol. 40, no. 14, pp. 1132-1139. https://doi.org/10.1097/BRS.0000000000000971
Galimberti F, Lubelski D, Healy AT, Wang T, Abdullah KG, Nowacki AS et al. A Systematic Review of Lumbar Fusion Rates with and Without the Use of rhBMP-2. Spine. 2015 Jul 15;40(14):1132-1139. https://doi.org/10.1097/BRS.0000000000000971
Galimberti, Fabrizio ; Lubelski, Daniel ; Healy, Andrew T. ; Wang, Timothy ; Abdullah, Kalil G. ; Nowacki, Amy S. ; Benzel, Edward C. ; Mroz, Thomas E. / A Systematic Review of Lumbar Fusion Rates with and Without the Use of rhBMP-2. In: Spine. 2015 ; Vol. 40, No. 14. pp. 1132-1139.
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abstract = "Study Design. Systematic review. Objective. To evaluate literature comparing fusion rates in anterior lumbar interbody fusion (ALIF), posterior lumbar interbody/transforaminal lumbar interbody fusion (PLIF/TLIF), and posterolateral lumbar fusion (PLF) with and without recombinant human bone morphogenetic protein-2 (rhBMP-2). Summary of Background Data. rhBMP-2 is used for the FDA-approved indication of single-level ALIF with LT-Cage and off-label for PLIF/TLIF, and PLF. Due to recent controversies, it is essential to evaluate the literature for its effects on fusion rates to evaluate whether benefits outweigh potential complications. Methods. A Medline search was performed of clinical studies published between May 2000 and May 2012 comparing fusion rates after ALIF, PLIF/TLIF, and PLF surgery with versus without rhBMP-2. Only studies with a control arm were reviewed. Results. 16 studies were reviewed (1794 patients, 995 treated with rhBMP-2 and 799 without). 5 of 5 studies for PLIF/TLIF (including 301 of 301 patients), 1 of 4 for ALIF (including 279 of 589 patients), and 3 of 7 for PLF (including 272 of 904 patients) reported no significant improvement in fusion rates with rhBMP-2 compared with those without rhBMP-2 at longest follow-up investigated. Average fusion rate 24 months after surgery was 97.8{\%} for ALIF (n = 316), 95.7{\%} for PLIF/TLIF (n = 141), and 93.6{\%} for PLF (n = 422) with rhBMP-2 and 88.2{\%} (n = 228), 89.5{\%} (n = 86), and 83.1{\%} (n = 372) without rhBMP-2, for ALIF, PLIF/TLIF, and PLF, respectively. Odds ratio of fusion were calculated as 7.08 (95{\%} CI: 1.54-32.7) in ALIF, 1.98 (95{\%} CI: 0.39-10.1) in PLIF/TLIF, and 3.06 (95{\%} CI: 1.61-5.80) in PLF with rhBMP-2 as compared with without rhBMP-2. Conclusion. Although numerous studies did not show statistically significant improvement in fusion rates with rhBMP-2 use, analysis of combined studies revealed significant improvement in fusion rate with rhBMP-2 in ALIF and PLF patients. Notably, even when pooling data from several studies, rhBMP-2 did not result in statistically significantly improved fusion rates in PLIF/TLIF. However, heterogeneity of rhBMP-2 dosing, surgical techniques, and quality of papers reviewed may limit the validity of conclusions drawn.",
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T1 - A Systematic Review of Lumbar Fusion Rates with and Without the Use of rhBMP-2

AU - Galimberti, Fabrizio

AU - Lubelski, Daniel

AU - Healy, Andrew T.

AU - Wang, Timothy

AU - Abdullah, Kalil G.

AU - Nowacki, Amy S.

AU - Benzel, Edward C.

AU - Mroz, Thomas E.

PY - 2015/7/15

Y1 - 2015/7/15

N2 - Study Design. Systematic review. Objective. To evaluate literature comparing fusion rates in anterior lumbar interbody fusion (ALIF), posterior lumbar interbody/transforaminal lumbar interbody fusion (PLIF/TLIF), and posterolateral lumbar fusion (PLF) with and without recombinant human bone morphogenetic protein-2 (rhBMP-2). Summary of Background Data. rhBMP-2 is used for the FDA-approved indication of single-level ALIF with LT-Cage and off-label for PLIF/TLIF, and PLF. Due to recent controversies, it is essential to evaluate the literature for its effects on fusion rates to evaluate whether benefits outweigh potential complications. Methods. A Medline search was performed of clinical studies published between May 2000 and May 2012 comparing fusion rates after ALIF, PLIF/TLIF, and PLF surgery with versus without rhBMP-2. Only studies with a control arm were reviewed. Results. 16 studies were reviewed (1794 patients, 995 treated with rhBMP-2 and 799 without). 5 of 5 studies for PLIF/TLIF (including 301 of 301 patients), 1 of 4 for ALIF (including 279 of 589 patients), and 3 of 7 for PLF (including 272 of 904 patients) reported no significant improvement in fusion rates with rhBMP-2 compared with those without rhBMP-2 at longest follow-up investigated. Average fusion rate 24 months after surgery was 97.8% for ALIF (n = 316), 95.7% for PLIF/TLIF (n = 141), and 93.6% for PLF (n = 422) with rhBMP-2 and 88.2% (n = 228), 89.5% (n = 86), and 83.1% (n = 372) without rhBMP-2, for ALIF, PLIF/TLIF, and PLF, respectively. Odds ratio of fusion were calculated as 7.08 (95% CI: 1.54-32.7) in ALIF, 1.98 (95% CI: 0.39-10.1) in PLIF/TLIF, and 3.06 (95% CI: 1.61-5.80) in PLF with rhBMP-2 as compared with without rhBMP-2. Conclusion. Although numerous studies did not show statistically significant improvement in fusion rates with rhBMP-2 use, analysis of combined studies revealed significant improvement in fusion rate with rhBMP-2 in ALIF and PLF patients. Notably, even when pooling data from several studies, rhBMP-2 did not result in statistically significantly improved fusion rates in PLIF/TLIF. However, heterogeneity of rhBMP-2 dosing, surgical techniques, and quality of papers reviewed may limit the validity of conclusions drawn.

AB - Study Design. Systematic review. Objective. To evaluate literature comparing fusion rates in anterior lumbar interbody fusion (ALIF), posterior lumbar interbody/transforaminal lumbar interbody fusion (PLIF/TLIF), and posterolateral lumbar fusion (PLF) with and without recombinant human bone morphogenetic protein-2 (rhBMP-2). Summary of Background Data. rhBMP-2 is used for the FDA-approved indication of single-level ALIF with LT-Cage and off-label for PLIF/TLIF, and PLF. Due to recent controversies, it is essential to evaluate the literature for its effects on fusion rates to evaluate whether benefits outweigh potential complications. Methods. A Medline search was performed of clinical studies published between May 2000 and May 2012 comparing fusion rates after ALIF, PLIF/TLIF, and PLF surgery with versus without rhBMP-2. Only studies with a control arm were reviewed. Results. 16 studies were reviewed (1794 patients, 995 treated with rhBMP-2 and 799 without). 5 of 5 studies for PLIF/TLIF (including 301 of 301 patients), 1 of 4 for ALIF (including 279 of 589 patients), and 3 of 7 for PLF (including 272 of 904 patients) reported no significant improvement in fusion rates with rhBMP-2 compared with those without rhBMP-2 at longest follow-up investigated. Average fusion rate 24 months after surgery was 97.8% for ALIF (n = 316), 95.7% for PLIF/TLIF (n = 141), and 93.6% for PLF (n = 422) with rhBMP-2 and 88.2% (n = 228), 89.5% (n = 86), and 83.1% (n = 372) without rhBMP-2, for ALIF, PLIF/TLIF, and PLF, respectively. Odds ratio of fusion were calculated as 7.08 (95% CI: 1.54-32.7) in ALIF, 1.98 (95% CI: 0.39-10.1) in PLIF/TLIF, and 3.06 (95% CI: 1.61-5.80) in PLF with rhBMP-2 as compared with without rhBMP-2. Conclusion. Although numerous studies did not show statistically significant improvement in fusion rates with rhBMP-2 use, analysis of combined studies revealed significant improvement in fusion rate with rhBMP-2 in ALIF and PLF patients. Notably, even when pooling data from several studies, rhBMP-2 did not result in statistically significantly improved fusion rates in PLIF/TLIF. However, heterogeneity of rhBMP-2 dosing, surgical techniques, and quality of papers reviewed may limit the validity of conclusions drawn.

KW - anterior lumbar interbody fusion

KW - fusion rate

KW - lumbar fusion

KW - posterior lumbar interbody fusion

KW - posterolateral lumbar fusion

KW - recombinant human bone morphogenetic protein-2

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