"Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has."

Margaret Mead
Original article
peer-reviewed

Performance of an Annular Closure Device in a ‘Real-World’, Heterogeneous, At-Risk, Lumbar Discectomy Population



Abstract

Study design/setting

Retrospective analysis of single-center registry outcomes data.

Objective

Assess the utility of an annular closure device (ACD) as an adjunct to limited discectomy for lumbar disc herniation (LDH).

Background

Recurrent lumbar disc herniation (rLDH) following limited discectomy persists at clinically significant rates, especially in large annular defect (at least 6 mm width) patients. While the etiology of reherniation is often multifactorial, inadequate annular occlusion remains one of the foremost considerations. Accordingly, annular closure has emerged as a promising technique and is the focus of this analysis.

Methods

This was a retrospective analysis of 171 patients who underwent limited lumbar discectomy with an ACD for LDH. Standardized patient assessment was performed preoperatively, three months postoperatively, and 12 months postoperatively, in addition to self-presented visits. No minimum last follow-up was required for inclusion. Oswestry Disability Index (ODI) and Visual Analog Scale (VAS Leg/Back) pain scores were collected at all visits. Plain radiographs were obtained at all visits, with magnetic resonance imaging (MRI) scans performed annually and/or when patients presented as symptomatic. ACD-related complications due to partial or complete mesh detachment from the titanium anchor were reported. All secondary surgical interventions were also reported. The Wilcoxon Rank-sum test was used to compare outcomes and events between sub-groups (p < 0.05).

Results

Mean last follow-up for all patients was 15 months. Large annular defects were present in 154 patients (90%). Symptomatic reherniations were observed in six patients (3.5%; five were present in the large annular defect subpopulation). All patients demonstrated clinically meaningful improvement in clinical outcome scores at both follow-up intervals. ACD mesh detachment was observed in 15 patients (8.8%; two underwent a subsequent surgical intervention). No symptomatic reherniations were observed in secondary herniation patients compared to six (4.1%) in the primary herniation group (p = 0.60).

Conclusions

Annular closure with the ACD results in clinically meaningful improvements in both primary and secondary LDH patients, with decreased rates of reherniation in high-risk patients compared to previous discectomy reports.



Want to read more?

Create a free account to continue reading this article.

Already a member? Login.



Original article
peer-reviewed

Performance of an Annular Closure Device in a ‘Real-World’, Heterogeneous, At-Risk, Lumbar Discectomy Population


Author Information

Adisa Kuršumović Corresponding Author

Neurosurgery, Spinal Surgery, and Interventional Neuroradiology, Donauisar Klinikum Deggendorf

Stefan Rath

Neurosurgery, Spinal Surgery, and Interventional Neuroradiology, Donauisar Klinikum Deggendorf


Ethics Statement and Conflict of Interest Disclosures

Human subjects: Consent was obtained by all participants in this study. The study protocol was approved by the local medical ethics committee. All clinical outcomes and patient imaging had been collected previously in accordance with institutional standard of care. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: Clinical research support from Intrinsic Therapeutics
Educational consultant for Intrinsic Therapeutics. Financial relationships: Adisa Kursumovic declare(s) personal fees from Intrinsic Therapeutics. Educational consulting fees. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.


Original article
peer-reviewed

Performance of an Annular Closure Device in a ‘Real-World’, Heterogeneous, At-Risk, Lumbar Discectomy Population


Figures etc.

Share
Original article
peer-reviewed

Performance of an Annular Closure Device in a ‘Real-World’, Heterogeneous, At-Risk, Lumbar Discectomy Population

Adisa Kuršumović">Adisa Kuršumović , Stefan Rath">Stefan Rath

  • Author Information
    Adisa Kuršumović Corresponding Author

    Neurosurgery, Spinal Surgery, and Interventional Neuroradiology, Donauisar Klinikum Deggendorf

    Stefan Rath

    Neurosurgery, Spinal Surgery, and Interventional Neuroradiology, Donauisar Klinikum Deggendorf


    Ethics Statement and Conflict of Interest Disclosures

    Human subjects: Consent was obtained by all participants in this study. The study protocol was approved by the local medical ethics committee. All clinical outcomes and patient imaging had been collected previously in accordance with institutional standard of care. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: Clinical research support from Intrinsic Therapeutics
    Educational consultant for Intrinsic Therapeutics. Financial relationships: Adisa Kursumovic declare(s) personal fees from Intrinsic Therapeutics. Educational consulting fees. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

    Acknowledgements


    Article Information

    Published: November 06, 2017

    DOI

    10.7759/cureus.1824

    Cite this article as:

    Kuršumović A, Rath S (November 06, 2017) Performance of an Annular Closure Device in a ‘Real-World’, Heterogeneous, At-Risk, Lumbar Discectomy Population. Cureus 9(11): e1824. doi:10.7759/cureus.1824

    Publication history

    Received by Cureus: September 19, 2017
    Peer review began: October 03, 2017
    Peer review concluded: November 02, 2017
    Published: November 06, 2017

    Copyright

    © Copyright 2017
    Kuršumović et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 3.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

    License

    This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Study design/setting

Retrospective analysis of single-center registry outcomes data.

Objective

Assess the utility of an annular closure device (ACD) as an adjunct to limited discectomy for lumbar disc herniation (LDH).

Background

Recurrent lumbar disc herniation (rLDH) following limited discectomy persists at clinically significant rates, especially in large annular defect (at least 6 mm width) patients. While the etiology of reherniation is often multifactorial, inadequate annular occlusion remains one of the foremost considerations. Accordingly, annular closure has emerged as a promising technique and is the focus of this analysis.

Methods

This was a retrospective analysis of 171 patients who underwent limited lumbar discectomy with an ACD for LDH. Standardized patient assessment was performed preoperatively, three months postoperatively, and 12 months postoperatively, in addition to self-presented visits. No minimum last follow-up was required for inclusion. Oswestry Disability Index (ODI) and Visual Analog Scale (VAS Leg/Back) pain scores were collected at all visits. Plain radiographs were obtained at all visits, with magnetic resonance imaging (MRI) scans performed annually and/or when patients presented as symptomatic. ACD-related complications due to partial or complete mesh detachment from the titanium anchor were reported. All secondary surgical interventions were also reported. The Wilcoxon Rank-sum test was used to compare outcomes and events between sub-groups (p < 0.05).

Results

Mean last follow-up for all patients was 15 months. Large annular defects were present in 154 patients (90%). Symptomatic reherniations were observed in six patients (3.5%; five were present in the large annular defect subpopulation). All patients demonstrated clinically meaningful improvement in clinical outcome scores at both follow-up intervals. ACD mesh detachment was observed in 15 patients (8.8%; two underwent a subsequent surgical intervention). No symptomatic reherniations were observed in secondary herniation patients compared to six (4.1%) in the primary herniation group (p = 0.60).

Conclusions

Annular closure with the ACD results in clinically meaningful improvements in both primary and secondary LDH patients, with decreased rates of reherniation in high-risk patients compared to previous discectomy reports.



Want to read more?

Create a free account to continue reading this article.

Already a member? Login.



Adisa Kuršumović, M.D.

Neurosurgery, Spinal Surgery, and Interventional Neuroradiology, Donauisar Klinikum Deggendorf

For correspondence:
adisa.kursumovic@donau-isar-klinikum.de

Stefan Rath

Neurosurgery, Spinal Surgery, and Interventional Neuroradiology, Donauisar Klinikum Deggendorf

Adisa Kuršumović, M.D.

Neurosurgery, Spinal Surgery, and Interventional Neuroradiology, Donauisar Klinikum Deggendorf

For correspondence:
adisa.kursumovic@donau-isar-klinikum.de

Stefan Rath

Neurosurgery, Spinal Surgery, and Interventional Neuroradiology, Donauisar Klinikum Deggendorf