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Two-year real-world results of lumbar discectomy with bone-anchored annular closure in patients at high risk of reherniation

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Abstract

Purpose

To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice.

Methods

This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6 weeks, 12 weeks, 26 weeks, 1 year, and 2 years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20 mm decrease relative to baseline for leg pain severity, ≥ 20 mm decrease for back pain severity, and ≥ 15-point decrease for ODI.

Results

Among 75 high-risk patients (mean age 45 years, 59% female), the cumulative event incidence through 2 years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI.

Conclusion

In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients.

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Acknowledgements

Intrinsic Therapeutics provided funding for data analysis and manuscript development.

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Authors and Affiliations

  1. Section for Spine Surgery, Klinikum Itzehoe, Robert-Koch-Str. 2, 25524, Itzehoe, Germany

    Ardeshir Ardeshiri

  2. Miller Scientific Consulting, Inc., 1854 Hendersonville Road, #231, Asheville, NC, USA

    Larry E. Miller

  3. Department for Neurosurgery, Medical University Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria

    Claudius Thomé

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  1. Ardeshir Ardeshiri
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  2. Larry E. Miller
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  3. Claudius Thomé
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Correspondence to Ardeshir Ardeshiri.

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AA, LM, and CT disclose consultancy with Intrinsic Therapeutics. The authors maintain full control of study data and agree to allow the journal to review the data upon request.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments.

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Informed consent was obtained from all individual participants included in the study.

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Ardeshiri, A., Miller, L.E. & Thomé, C. Two-year real-world results of lumbar discectomy with bone-anchored annular closure in patients at high risk of reherniation. Eur Spine J 28, 2572–2578 (2019). https://doi.org/10.1007/s00586-019-06036-8

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  • DOI: https://doi.org/10.1007/s00586-019-06036-8

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