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rhBMP use in cervical spine surgery: associated factors and in-hospital complications
Amit Jain1, Hamid Hassanzadeh1, Sophia A Strike1
1c/o Elaine P. Henze, BJ, ELS, Medical Editor and Director, Editorial Services, Department of Orthopaedic Surgery, The Johns Hopkins University, Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, #A665, Baltimore, MD 21224-2780. E-mail address: ehe.
Background:
Widespread use of recombinant human bone morphogenetic protein (rhBMP) in cervical spine surgery has continued despite the U.S. Food and Drug Administration's 2008 notification regarding its adverse effects. Our study goals were to analyze how patient, surgical, and institutional factors influenced rhBMP use in cervical spinal fusion surgery and to examine the cervical-spine-specific in-hospital complications associated with rhBMP use.
Methods:
The Nationwide Inpatient Sample database was used to identify 1,064,372 patients eighteen years or older who had undergone cervical spinal fusion surgery from 2003 through 2010. Of these patients, 84,726 (7.96%) received rhBMP. Multivariate logistic regression models were used to analyze patient, surgical, and institutional factors associated with rhBMP use, and the relationship between rhBMP use and the development of in-hospital complications.
Results:
On multivariate analysis, patient age and sex, insurance type, surgical approach, use of autograft bone, and hospital teaching status, size, and region were significant predictors of rhBMP use. Use of rhBMP was a significant predictor of complications on univariate analysis and on multivariate analysis adjusted for patient age and sex, Charlson comorbidity score, insurance status, surgical approach, autograft bone use, and hospital teaching status, size, and region. Use of rhBMP was significantly associated with the development of dysphagia (prevalence, 2.0%; adjusted odds ratio [OR], 1.53), dysphonia (prevalence, 0.28%; adjusted OR, 1.48), hematoma/seroma formation (prevalence, 0.7%; adjusted OR, 1.24), and neurological complications (prevalence, 0.84%; adjusted OR, 2.0). These complications were most commonly found after anterior cervical fusion surgery. Wound infections and neurological complications were most commonly found after posterior cervical fusion surgery. Dysphagia was most commonly found after circumferential fusion surgery.
Conclusions:
Indications for rhBMP use for cervical spinal fusion are multifactorial. Its use is associated with a significantly higher likelihood of cervical-spine-specific complications.
Insights
Recombinant human bone morphogenetic protein (rhBMP) use in cervical spine surgery is linked to increased risks of complications like dysphagia and neurological issues. Patient, surgical, and hospital factors influence its application, despite known adverse effects.
Area of Science:
- Spine Surgery
- Orthopedic Surgery
- Biomaterials in Medicine
Background:
- Recombinant human bone morphogenetic protein (rhBMP) use persists in cervical spine surgery despite FDA warnings on adverse effects.
- Factors influencing rhBMP adoption and associated complications require detailed analysis.
Purpose of the Study:
- To investigate patient, surgical, and institutional factors affecting rhBMP use in cervical spinal fusion.
- To examine in-hospital complications specifically related to rhBMP in cervical spine fusion.
Main Methods:
- Analysis of the Nationwide Inpatient Sample database (2003-2010) including 1,064,372 patients undergoing cervical spinal fusion.
- Multivariate logistic regression models to identify predictors of rhBMP use and its association with complications.
- Stratified analysis of complications based on surgical approach (anterior, posterior, circumferential).
Main Results:
- Significant predictors of rhBMP use included patient age, sex, insurance, surgical approach, autograft use, and hospital characteristics.
- rhBMP use was independently associated with higher rates of dysphagia, dysphonia, hematoma/seroma, and neurological complications.
- Complication patterns varied by surgical approach, with dysphagia common in anterior/circumferential and neurological issues in posterior fusions.
Conclusions:
- rhBMP indications for cervical spinal fusion are multifactorial, influenced by patient, surgical, and institutional variables.
- rhBMP use is significantly correlated with an increased incidence of cervical-spine-specific in-hospital complications.
