“Patients treated with BMP-2 were further divided by the delivery location—posterior-only, interbody only, or interbody plus posterior,” said Dr. Bess.Patients in the interbody plus posterior BMP-2 cohort were generally older, had a greater Charlson comorbidity index, longer operating room times, and greater estimated blood loss compared to patients who did not receive BMP-2. Follow-up was a mean 30.3 months, and ranged from 12.2 to 47.9 months.

AAOS Now

Published 1/1/2014
|
Peter Pollack

BMP-2 Treatment Results in Different Complication Trends in ASD Patients

Study data finds similar outcomes, but distinct trends

Patients with adult spinal deformity (ASD) who are treated with recombinant human bone morphogenetic protein-2 (BMP-2) are likely to see a different—but not necessarily more beneficial—pattern of complications than those treated without BMP-2, according to research presented at the 2013 annual meeting of the North American Spine Society (NASS).

“We looked at 1-year postoperative complication rates for 261 participants in a prospective, multicenter, consecutive ASD cohort,” explained presenter R. Shay Bess, MD.

Patients included in the study met the following criteria:

  • Complete demographic, radiographic, and operative data were available at minimum 1-year follow-up.
  • Patients were at least 18 years of age with at least four pedicle screw fixation fusion levels.

Of the 261 ASD patients who met the criteria, 158 were treated with BMP-2 and 103 were treated without it.

Radiograph showing placement of BMP-2 in patient with adult spinal deformity.
Courtesy of R. Shay Bess, MD

 

Differing trends
From 0 to 3 months after treatment, the research team found that ASD patients who did not receive BMP-2 had fewer total complications than those who underwent treatment with BMP-2. In addition, BMP-2–treated ASD patients had more minor complications per patient.

At 3 to 12 months, however, the situation reversed; ASD patients not treated with BMP-2 had a greater percentage of total complications. In addition, they had a higher likelihood of implant failure and were more likely to have complications that required surgery. Neurologic, wound, and infection complications were similar for all groups through all time frames.

“Based on univariate analysis, we found that ASD patients in the BMP-2 cohorts were more likely to experience early complications,” said Dr. Bess, “but these were primarily minor. ASD patients who did not receive BMP-2 were at comparatively greater risk of major complications, implant failures, and return to the operating room. This continued to hold true when we broke down the data based on location of BMP use.”

According to Dr. Bess, through a multivariate analysis the researchers found that major complications, deep infections, return to the operating room, and implant failures were not associated with BMP use. However, he pointed out that the multivariate analysis evaluating the variables associated with these complications demonstrated that the correlation coefficients were very small.

Dr. Bess suggested that future research in this area should focus on consistent and advanced data analysis, long-term complications, fusion rates, and quality of life outcomes.

Dr. Bess’ coauthors for “Complications are Different for Recombinant Human Bone Morphogenetic Protein-2 (BMP) versus No BMP Use in Adult Spinal Deformity (ASD): An Analysis of Variance in Complication Timing, Profile and Consequences” include: Breton G. Line, BS; Virginie Lafage, PhD; Frank J. Schwab, MD; Behrooz A. Akbarnia, MD; Christopher P. Ames, MD; Oheneba Boachie-Adjei, MD; Douglas C. Burton, MD; Vedat Deviren, MD; Jacob M. Buchowski, MD, MS; Robert A. Hart, MD; Khaled M. Kebaish, MD; Eric O. Klineberg, MD; Munish C. Gupta, MD; Thomas J. Errico, MD; Gregory M. Mundis, Jr, MD; Richard A. Hostin, MD; and Justin S. Smith, MD, PhD.

Disclosure information: Dr. Bess—Pioneer, AlloSource, DePuy Spine, Alphatec, Medtronic, Orthopaedic Research and Education Foundation (OREF); Mr. Line—no conflicts; Dr. Lafage,—Nemaris, Medtronic, DePuy Spine, Scoliosis Research Society (SRS); Dr. Schwab—Medtronic, Nemaris, DePuy Spine, SRS; Dr. Akbarnia—DePuy Spine; NuVasive, K2M, Ellipse, KSpine, OREF; Dr. Ames—Aesculap, Stryker, Lanx, Trans1, Doctors Research Group, Visualase, Medtronic, DePuy; Dr. Boachie-Adjei—K2M, DePuy, Trans1, SRS, Medtronic; Dr. Burton—DePuy Spine, International Spine Study Group (ISSG); Dr. Deviren—Stryker, Medtronic, NuVasive, Guidepoint, Globus; Dr. Buchowski—Stryker, CoreLink, Globus Medical, Medtronic, DePuy, Global Spine Tumor Society Study Group, ISSG, SRS, Spine Deformity, Journal of Bone & Joint Surgery, Spine, Complex Spine Study Group, CSSG/K2M; Dr. Hart—DePuy, SeaSpine, Kyphon, Medtronic, Synthes, Eli Lilly, Spine Connect, OREF, Cervical Spine Research Society, Spine, The Spine Journal, American Orthopaedic Association, Lumbar Spine Research Society, OREF, SRS; Dr. Kebaish—K2M; Dr. Klineberg—Synthes/DePuy, AOSpine, OREF; Dr. Gupta—DePuy Spine, Pioneer, Johnson & Johnson, Procter & Gamble, Pfizer, Spinal Ventures, Medtronic, Orthofix, Federation of Spine Associations, SRS; Dr. Errico—K2M, Fastenetix, Setting Scoliosis Straight, Paradigm Spine, Fridolin Trust, AOSpine, OREF, OMeGA; Dr. Mundis—NuVasive, K2M, DePuy, Integra, OREF; Dr. Hostin—DePuy Spine; Dr. Smith—Axial Biotech, Medtronic, Biomet.

Peter Pollack is electronic content specialist for AAOS Now. He can be reached at ppollack@aaosnow.org

Bottom Line

  • This prospective, multicenter study examined postoperative complications in patients with adult spinal deformity (ASD) treated with recombinant human bone morphogenetic protein-2 (BMP-2) compared to similar patients who did not receive BMP-2.
  • Within the first 3 months after surgery, ASD patients treated with BMP-2 had more minor complications per patient than those who did not receive BMP-2.
  • However, this situation later reversed; ASD patients not treated with BMP-2 had a higher likelihood of more serious complications, including implant failure and a return to the operating room.
  • Regardless of whether the patient was treated with BMP-2 or not, the incidence of neurologic, wound, and infection complications was similar through all time frames.