Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study

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Abstract

Summary

This pilot monocenter study in 30 patients with painful osteoporotic vertebral compression fractures compared two vertebral augmentation procedures. Over a 3-year post-surgery follow-up, pain/disability/quality of life remained significantly improved with both balloon kyphoplasty and SpineJack® techniques, but the latter allowed better vertebral body height restoration/kyphosis correction.

Introduction

Patient follow-up rarely exceed 2 years in trials comparing vertebral augmentation procedures for the treatment of painful osteoporotic vertebral compression fractures (VCFs). This pilot, investigator-initiated, prospective study aimed to compare long-term results of SpineJack® (SJ) and balloon kyphoplasty (BKP). Preliminary results showed that SJ resulted in a better restoration of vertebral heights and angles, maintained over 12 months.

Methods

Thirty patients were randomized to SJ (n = 15) or BKP (n = 15). Clinical endpoints were analgesic consumption, back pain intensity (visual analog scale (VAS)), the Oswestry Disability Index (ODI), and quality of life (EQ-VAS score). They were recorded preoperatively, at 5 days (except EQ-VAS), 1, 3, 6, 12, and 36 months post-surgery. Spine X-rays were taken 48 h prior to the procedure and 5 days, 6, 12, and 36 months after.

Results

Clinical improvements were observed with both procedures over the 3-year period without significant inter-group differences, but the final mean EQ-5Dindex score was significantly in favor of the SJ group (0.93 ± 0.11 vs 0.81 ± 0.09; p = 0.007). Vertebral height restoration/kyphotic correction was still evident at 36 months with a greater mean correction of anterior (10 ± 13% vs 2 ± 8% for BKP, p = 0.007) and central height (10 ± 11% vs 3 ± 7% for BKP, p = 0.034) and a larger correction of the vertebral body angle (− 5.0° ± 5.1° vs 0.4° ± 3.4°; p = 0.003) for SJ group.

Conclusions

In this study, both techniques displayed very good long-term clinical efficiency and safety in patients with osteoporotic VCFs. Over the 3-year follow-up, vertebral body height restoration/kyphosis correction was better with the SpineJack® procedure.

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Change history

  • 18 January 2019

    The author list was incomplete. The complete list of authors is the following: D. Noriega, F. Rodrίguez-Monsalve, R. Ramajo, I.Sánchez-Lite, B. Toribio, F. Ardura. The corresponding author regrets sincerely this error. The original article got update.

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Noriega, D.C., Rodrίguez-Monsalve, F., Ramajo, R. et al. Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study. Osteoporos Int 30, 637–645 (2019). https://doi.org/10.1007/s00198-018-4773-5

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Keywords

  • Back pain
  • Balloon kyphoplasty
  • Osteoporosis
  • SpineJack
  • Vertebral augmentation
  • Vertebral compression fracture