TY - JOUR
T1 - Use of rhBMP-2 for adult spinal deformity surgery
T2 - patterns of usage and changes over the past decade
AU - Bannwarth, Mathieu
AU - Smith, Justin S.
AU - Bess, Shay
AU - Klineberg, Eric O.
AU - Ames, Christopher P.
AU - Mundis, Gregory M.
AU - Kim, Han Jo
AU - Lafage, Renaud
AU - Gupta, Munish C.
AU - Burton, Douglas C.
AU - Shaffrey, Christopher I.
AU - Schwab, Frank J.
AU - Lafage, Virginie
N1 - Funding Information:
DePuy Synthes, Stryker, and Carlsmed; direct stock ownership in NuVasive and Alphatec; clinical or research support for the study described from DePuy Synthes; support of non–study-related clinical or research effort from DePuy Synthes, NuVasive, and AO Spine; and royalties from Zimmer Biomet, NuVasive, and Thieme. Dr. Bess: consultant for K2M Stryker and Miru; direct stock ownership in Progenerative Medical and Carlsmed; patent holder with K2M Stryker and NuVasive; clinical or research support for the study described from ISSGF, K2M Stryker, NuVasive, and DePuy Synthes; support of non–study-related clinical or research effort from ISSGF, NuVasive, Medtronic, DePuy Synthes, K2M Stryker, SI-Bone, and SeaSpine; speakers bureau for K2M Stryker; and royalties from K2M Stryker and NuVasive. Dr. Klineberg: consultant for DePuy Synthes, Stryker, and Medicrea/Medtronic; honoraria from AO Spine; and fellowship grant from AO Spine. Dr. Ames: employee of UCSF; royalties from Stryker, Biomet Zimmer Spine, DePuy Synthes, NuVasive, Next Orthosurgical, K2M, and Medicrea; consultant for DePuy Synthes, Medtronic, Medicrea, and K2M; research support from DePuy Synthes, Titan Spine, and ISSG; editorial board of Operative Neurosurgery; grant funding from SRS; executive committee of ISSG; and director of Global Spinal Analytics. Dr. Mundis: consultant for NuVa-sive, Viseon, SeaSpine, and Carlsmed; direct stock ownership in NuVasive, SeaSpine, Alphatec, and Surgalign; patent holder with Stryker, SeaSpine, and NuVasive; and royalties from NuVasive and Stryker. Dr. Kim: royalties from Zimmer Biomet and K2M Stryker; clinical or research support for the study described from ISSGF; and fellowship grant to hospital from AO Spine. Mr. R Lafage: ownership in Nemaris. Dr. Gupta: royalties from DePuy, Innomed, and Globus; consultant for DePuy, Medtronic, Globus, and Alphatec; honoraria from AO Spine; direct stock ownership in J&J and P&G; and travel for faculty/meeting from Scoliosis Research Society, AO Spine, DePuy, Globus, Medtronic, Medi-crea, Mizuho, and Alphatec. Dr. Burton: direct stock ownership in Progenerative Medical; royalties from DePuy; clinical or research support for the study described from ISSGF; and consultant for Globus. Dr. Shaffrey: consultant for Medtronic, NuVasive, and SI-Bone; direct stock ownership in NuVasive; patent holder with Medtronic, NuVasive, and Zimmer Biomet; and royalties from NuVasive. Dr. Schwab: consultant for Globus Medical and Zimmer Biomet; royalties from Zimmer Biomet and Medtronic; and executive committee of the International Spine Study Group. Dr. V Lafage: consultant for Globus Medical; royalties from NuVa-sive; honoraria from DePuy Synthes and Implanet; and direct stock ownership in Nemaris.
Publisher Copyright:
© 2021. All Rights Reserved.
PY - 2021/6
Y1 - 2021/6
N2 - OBJECTIVE Recombinant human bone morphogenetic protein–2 (rhBMP-2) has been shown to increase fusion rates; however, cost, limited FDA approval, and possible complications impact its use. Decisions regarding rhBMP-2 use and changes over time have not been well defined. In this study, the authors aimed to assess changes in rhBMP-2 use for adult spinal deformity (ASD) surgery over the past decade. METHODS A retrospective review of the International Spine Study Group prospective multicenter database was performed to identify ASD patients treated surgically from 2008 to 2018. For assessment of rhBMP-2 use over time, 3 periods were created: 2008–2011, 2012–2015, and 2016–2018. RESULTS Of the patients identified, 1180 met inclusion criteria, with a mean age 60 years and 30% of patients requiring revision surgery; rhBMP-2 was used in 73.9% of patients overall. The mean rhBMP-2 dose per patient was 23.6 mg. Patients receiving rhBMP-2 were older (61 vs 58 years, p < 0.001) and had more comorbidities (Charlson Comorbidity Index 1.9 vs 1.4, p < 0.001), a higher rate of the Scoliosis Research Society–Schwab pelvic tilt modifier (> 0; 68% vs 62%, p = 0.026), a greater deformity correction (change in pelvic incidence minus lumbar lordosis 15° vs 12°, p = 0.01), and more levels fused (8.9 vs 7.9, p = 0.003). Over the 3 time periods, the overall rate of rhBMP-2 use increased and then stabilized (62.5% vs 79% vs 77%). Stratified analysis showed that after an overall increase in rhBMP-2 use, only patients who were younger than 50 years, those who were smokers, those who received a three-column osteotomy (3CO), and patients who underwent revision sustained an increased rate of rhBMP-2 use between the later two periods. No similar increases were noted for older patients, nonsmokers, primary surgery patients, and patients without a 3CO. The total rhBMP-2 dose decreased over time (26.6 mg vs 24.8 mg vs 20.7 mg, p < 0.001). After matching patients by preoperative alignment, 215 patients were included, and a significantly lower rate of complications leading to revision surgery was observed within the 2012–2015 period compared with the 2008–2011 (21.4% vs 13.0%, p = 0.029) period, while rhBMP-2 was increasingly used (80.5% vs 66.0%, p = 0.001). There was a trend toward a lower rate of pseudarthrosis for patients in the 2012–2015 period, but this difference did not reach statistical significance (7% vs 4.2%, p = 0.283). CONCLUSIONS The authors found that rhBMP-2 was used in the majority of ASD patients and was more commonly used in those with greater deformity correction. Additionally, over the last 10 years, rhBMP-2 was increasingly used for ASD patients, but the dose has decreased. https://thejns.org/doi/abs/10.3171/202L3.FOCUS2164
AB - OBJECTIVE Recombinant human bone morphogenetic protein–2 (rhBMP-2) has been shown to increase fusion rates; however, cost, limited FDA approval, and possible complications impact its use. Decisions regarding rhBMP-2 use and changes over time have not been well defined. In this study, the authors aimed to assess changes in rhBMP-2 use for adult spinal deformity (ASD) surgery over the past decade. METHODS A retrospective review of the International Spine Study Group prospective multicenter database was performed to identify ASD patients treated surgically from 2008 to 2018. For assessment of rhBMP-2 use over time, 3 periods were created: 2008–2011, 2012–2015, and 2016–2018. RESULTS Of the patients identified, 1180 met inclusion criteria, with a mean age 60 years and 30% of patients requiring revision surgery; rhBMP-2 was used in 73.9% of patients overall. The mean rhBMP-2 dose per patient was 23.6 mg. Patients receiving rhBMP-2 were older (61 vs 58 years, p < 0.001) and had more comorbidities (Charlson Comorbidity Index 1.9 vs 1.4, p < 0.001), a higher rate of the Scoliosis Research Society–Schwab pelvic tilt modifier (> 0; 68% vs 62%, p = 0.026), a greater deformity correction (change in pelvic incidence minus lumbar lordosis 15° vs 12°, p = 0.01), and more levels fused (8.9 vs 7.9, p = 0.003). Over the 3 time periods, the overall rate of rhBMP-2 use increased and then stabilized (62.5% vs 79% vs 77%). Stratified analysis showed that after an overall increase in rhBMP-2 use, only patients who were younger than 50 years, those who were smokers, those who received a three-column osteotomy (3CO), and patients who underwent revision sustained an increased rate of rhBMP-2 use between the later two periods. No similar increases were noted for older patients, nonsmokers, primary surgery patients, and patients without a 3CO. The total rhBMP-2 dose decreased over time (26.6 mg vs 24.8 mg vs 20.7 mg, p < 0.001). After matching patients by preoperative alignment, 215 patients were included, and a significantly lower rate of complications leading to revision surgery was observed within the 2012–2015 period compared with the 2008–2011 (21.4% vs 13.0%, p = 0.029) period, while rhBMP-2 was increasingly used (80.5% vs 66.0%, p = 0.001). There was a trend toward a lower rate of pseudarthrosis for patients in the 2012–2015 period, but this difference did not reach statistical significance (7% vs 4.2%, p = 0.283). CONCLUSIONS The authors found that rhBMP-2 was used in the majority of ASD patients and was more commonly used in those with greater deformity correction. Additionally, over the last 10 years, rhBMP-2 was increasingly used for ASD patients, but the dose has decreased. https://thejns.org/doi/abs/10.3171/202L3.FOCUS2164
KW - adult spinal deformity
KW - arthrodesis
KW - bone morphogenetic protein
KW - fusion
KW - instrumentation
KW - pseudarthrosis
KW - rhBMP-2
KW - spine surgery
UR - http://www.scopus.com/inward/record.url?scp=85107458798&partnerID=8YFLogxK
U2 - 10.3171/2021.3.FOCUS2164
DO - 10.3171/2021.3.FOCUS2164
M3 - Article
C2 - 34062501
AN - SCOPUS:85107458798
SN - 1092-0684
VL - 50
SP - 1
EP - 9
JO - Neurosurgical Focus
JF - Neurosurgical Focus
IS - 6
ER -