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Baclofen pumps do not increase risk of complications following spinal fusion

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Abstract

Purpose

To assess the complication risks associated with intrathecal baclofen (ITB) pumps in cerebral palsy (CP) patients undergoing posterior spinal fusion (PSF) and to determine if timing of pump implantation before or during PSF impacts the risk of complications.

Methods

A prospectively collected multicenter database was retrospectively reviewed to identify CP patients undergoing PSF from 2008 to 2023. Patients were divided into 2 cohorts: those with an ITB pump (ITB cohort) and those without (non-ITB cohort). The ITB cohort was further categorized by placement of the pump prior to or during PSF. Cohorts were then compared in terms of postoperative complications, perioperative complications, and need for revision surgery.

Results

Four hundred six patients (ITB n = 79 [53 prior to, 26 during PSF], non-ITB n = 326) were included in this analysis. At an average follow-up of 4.0 years (range 2–10 years), there were no significant differences between the ITB and non-ITB cohorts in the rate of perioperative complications (5.0% vs 6.5%, p = 0.80), revision surgeries (2.5% vs 4.6%, p = 0.54), or any complication type, regardless of whether pumps were placed prior to or during PSF, aside from longer surgical times in the latter group.

Conclusion

Complication rates are similar for ITBs placed prior to and during PSF. Patients with spastic CP may safely be treated with ITB pumps without increased risks of complication or further reoperation/revision following PSF.

Level of evidence

Level III.

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Data availability

Data are available upon reasonable request.

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Acknowledgements

For editorial assistance, we thank Denise Di Salvo, MS, Sandra Crump, MPH, and Rachel Box, MS, in the Editorial Services group of The Johns Hopkins Department of Orthopaedic Surgery.

Funding

The Setting Scoliosis Straight Foundation provided support for the maintenance of the HARMS Study Group database. No other funding was received for the conduct of this study.

Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery, The Johns Hopkins Hospital University, Baltimore, MD, USA

    Kenneth H. Levy & Paul D. Sponseller

  2. Department of Orthopaedic Surgery, Rady Children’s Hospital, San Diego, CA, USA

    Burt Yaszay

  3. Department of Orthopaedic Surgery, University of Virginia School of Medicine, Charlottesville, VA, USA

    Mark F. Abel

  4. Department of Orthopaedic Surgery, Nemours Children’s Clinic, Wilmington, DE, USA

    Suken A. Shah

  5. Department of Orthopaedic Surgery, Shriners Hospital for Children, Philadelphia, PA, USA

    Amer F. Samdani

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  1. Kenneth H. Levy
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Consortia

HARMS Study Group

Contributions

KHL, BY, MFA, SAS, AFS, PDS, HSG: Made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work. KHL, BY, MFA, SAS, AFS, PDS, HSG: Drafted the work or revised it critically for important intellectual cont. KHL, BY, MFA, SAS, AFS, PDS, HSG: Approved the final version to be published. KHL, BY, MFA, SAS, AFS, PDS, HSG: Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Paul D. Sponseller.

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Conflict of interest

Kenneth H. Levy: no competing interests to declare that are relevant to the content of this article. Burt Yaszay: grants from Setting Scoliosis Straight, grants and personal fees from Stryker, grants and personal fees from NuVasive, grants and personal fees from DePuy Synthes, personal fees from Globus, personal fees from Orthopediatrics, personal fees from Medtronic, personal fees from Biogen. Burt Yaszay is an editorial board member for Spine Deformity. Mark F. Abel: no competing interests to declare that are relevant to the content of this article. Suken A. Shah: grants from Setting Scoliosis Straight Foundation, grants and non-financial support from DePuy Synthes Spine. Suken A. Shah is an editorial board member for Spine Deformity. Amer F. Samdani: grants from Setting Scoliosis Straight Foundation, personal fees from DePuy Synthes Spine, personal fees from Ethicon, personal fees from Globus Medical, personal fees from Medical Device Business Services, personal fees from Mirus, personal fees from NuVasive, personal fees from Orthofix, personal fees from Stryker, personal fees from Zimmer Biomet. Amer F. Samdani is an editorial board member for Spine Deformity. Paul D. Sponseller: personal fees from DePuy Synthes Spine, personal fees from Globus, personal fees from Pacira Biosciences, personal fees from Orthopediatrics, personal fees from Journal of Bone and Joint Surgery—American Volume.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the institutional review boards of all participating institutions.

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Levy, K.H., Yaszay, B., Abel, M.F. et al. Baclofen pumps do not increase risk of complications following spinal fusion. Spine Deform 12, 473–480 (2024). https://doi.org/10.1007/s43390-023-00786-8

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