A Retrospective Analysis of Complications Associated With Bone Morphogenetic Protein 2 in Anterior Lumbar Interbody Fusion

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Abstract

Study Design:

Retrospective review.

Objective:

The aim of our study was to quantify the frequency of complications associated with recombinant human bone morphogenetic protein 2 (rhBMP-2) use in anterior lumbar interbody fusion (ALIF).

Methods:

The orthopedic subset of the Medicare database (PearlDiver) was queried for this retrospective cohort study using International Statistical Classification of Diseases 9 (ICD-9) and Current Procedure Terminology (CPT) codes for ALIF procedures with and without rhBMP-2 between 2005 and 2010. Frequencies of complications and reoperations were then identified within 1 year from the index procedure. Complications included reoperations, pulmonary embolus, deep vein thrombosis, myocardial infarction, nerve-related complications, incision and drainage procedures, wound, sepsis, pneumonia, urinary tract infections, respiratory, heterotopic ossification, retrograde ejaculation, radiculopathy, and other medical complications. Odds ratios (ORs) and 95% confidence intervals (CIs) were used to assess the statistical significance.

Results:

We identified a total of 41 865 patients who had an ALIF procedure. A total of 14 384 patients received rhBMP-2 while 27 481 did not. Overall, 6016 (41.8%) complications within 1 year from surgery were noted within the group who received rhBMP-2 and 12 950 (47.1%) complications within 1 year from surgery were recorded in those who did not receive rhBMP-2 (OR = 0.81, CI = 0.77-0.84). Overall, exposure to rhBMP-2 was associated with significantly decreased odds of complications with exception to reoperation rates (0.9% rhBMP-2 vs 1.0% no rhBMP-2; OR = 0.88, CI = 0.71-1.09) and radiculopathy (4.4% rhBMP-2 vs 4.3% no rhBMP-2; OR = 1.02, CI = 0.93-1.13).

Conclusions:

The use of rhBMP-2 in patients undergoing ALIF procedure was associated with a significantly decreased rate of complications. Further studies are needed to elucidate a true incidence of complication.

Related collections

Most cited references 30

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A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned.

Eugene Carragee, Eric L Hurwitz, Bradley Weiner (2011)

Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight. To compare the conclusions regarding the safety and related efficacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases. Systematic review. Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efficacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses. There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2-associated adverse events (0%) were reported in any of these studies (99% confidence interval of adverse event rate <0.5%). The study designs of the industry-sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects reported early back pain and leg pain adverse events; higher doses of rhBMP-2 were also associated with a greater apparent risk of new malignancy. Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications. Copyright © 2011 Elsevier Inc. All rights reserved.

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Iliac crest bone graft harvest donor site morbidity. A statistical evaluation.

Linda Asher, J C Banwart, R Hassanein (1995)

This study analyzed the cause, rate, and risk factors of iliac crest bone graft donor site morbidity. All complications or problems, no matter how small, were sought to develop strategies of prevention. A wide range of major, 0.76% (Keller et al) to 25% (Summers et al) and minor complications, 9.4% (Keller et al) to 24% (Summers et al) has been reported. A consecutive series of 261 patients, whose bone graft harvest was done by one surgeon, was studied by chart review and a mail survey that was not conducted by the operating surgeon. The survey presented specific open-ended questions designed to uncover any complication/problem, no matter how small. Complications then were categorized as major or minor and subcategorized as acute or chronic. Statistical analysis was done using chi-squared and multiple logistical regression. None of the 261 patients had a severe perioperative complication--e.g., superior gluteal artery injury, sciatic nerve injury, or deep wound infection. None of the 225 patients with long term follow-up (average, 66 months; range, 32-105 months) had a severe late complication--e.g., donor site herniation, meralgia paresthetica, pelvic instability, or fracture. Of the 180 patients meeting the qualifications for statistical analysis, major complications occurred in 18 (10%), only three of which affected function (pain). Minor complications occurred in 70 (39%). The results indicated that severe complications from iliac crest bone graft harvest can be avoided and major complications affecting functioning are uncommon, but minor complications are common. The findings suggest that procedural refinements of limiting subcutaneous dissection and providing layered tension-free incision closure may improve results.

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Morbidity at bone graft donor sites.

Kenisha Younger, Fae Chapman (1988)

A review of the medical records of 239 patients with 243 autogenous bone grafts was undertaken to document the morbidity at the donor sites. The overall major complication rate was 8.6%. Major complications included infection (2.5%), prolonged wound drainage (0.8%), large hematomas (3.3%), reoperation (3.8%), pain greater than 6 months (2.5%), sensory loss (1.2%), and unsightly scars. Minor complications (20.6%) included superficial infection, minor wound problems, temporary sensory loss, and mild or resolving pain. There was a much higher complication rate (17.9% major) if the incision used for the surgery was also the same incision used to harvest the bone graft.

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Author and article information

Journal

Journal ID (nlm-ta): Global Spine J

Journal ID (iso-abbrev): Global Spine J

Journal ID (publisher-id): GSJ

Journal ID (hwp): spgsj

Title: Global Spine Journal

Publisher: SAGE Publications (Sage CA: Los Angeles, CA )

ISSN (Print): 2192-5682

ISSN (Electronic): 2192-5690

Publication date (Electronic): 06 April 2017

Publication date (Print): April 2017

Volume: 7

Issue: 2

Pages: 148-153

Affiliations

[1 ]University of Southern California, Los Angeles, CA, USA

[2 ]University of California at Los Angeles, CA, USA

[3 ]University of Utah, Salt Lake City, UT, USA

[4 ]Durango Orthopedic Associates, P.C./Spine Colorado, Durango, CO, USA

[5 ]Uijongbu St. Mary’s Hospital, The Catholic University of Korea, Uijongbu, Korea

[6 ]Emory Spine Center, Atlanta, GA, USA

[7 ]Bergmannstrost Hospital, Halle, Germany

Author notes

[*]Zorica Buser, Department of Orthopaedic Surgery, Keck School of Medicine, University of Southern California, Hoffman Medical Research Center HMR 710, 2011 Zonal Ave, Los Angeles, CA 90033, USA. Email: Zbuser@ 123456usc.edu

Article

Publisher ID: 10.1177_2192568217694010

DOI: 10.1177/2192568217694010

PMC ID: 5415156

SO-VID: cb5caae4-b480-4860-98cf-3f2f778a866d

License:

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 License ( http://www.creativecommons.org/licenses/by-nc-nd/4.0/) which permits non-commercial use, reproduction and distribution of the work as published without adaptation or alteration, without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

A Retrospective Analysis of Complications Associated With Bone Morphogenetic Protein 2 in Anterior Lumbar Interbody Fusion

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Abstract

Study Design:

Objective:

Methods:

Results:

Conclusions:

Related collections

Core Readings in Statistical Mediation Analysis

Most cited references 30

A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned.

Iliac crest bone graft harvest donor site morbidity. A statistical evaluation.

Morbidity at bone graft donor sites.

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