Treatment of spondylodiscitis

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Antibiotic‑loaded calcium sulfate beads in spinal surgery for patients with spondylodiscitis: a clinical retrospective study

 

Key points

    • ✔ Retrospective analysis of 32 patients undergoing treatment for spondylodiscitis with inclusion of antibiotic-loaded STIMULAN beads.
    • ✔ No recurrence of infection was seen over a 12-month period.
    • ✔ Significant improvements in pain, disability and inflammatory markers were reported in all patients.
    • ✔ Solid bone fusion was achieved in all patients with an average time of 4.6 months.
    • ✔ No perioperative complications were reported in this cohort. Study limitations include smaller sample size and lack of control arm.

 

Summary

Efficacy and safety of antibiotic-loaded calcium sulfate beads for the treatment of spondylodiscitis was reported by Tang, et al. (2022) in the retrospective study “Antibiotic‑loaded calcium sulfate beads in spinal surgery for patients with spondylodiscitis: a clinical retrospective study”. This study included 32 consecutive patients with lumbar/thoracic spondylodiscitis who were indicated for surgical intervention and reconstruction due to progressive biomechanical pain, refractoriness to antibiotic therapy, epidural abscesses, neurological impairment, or segmental instability. In all patients, debridement combined with percutaneous pedicle screw fixation was performed through a single-stage posterolateral approach. Antibiotic-loaded calcium sulfate beads (STIMULAN, vancomycin, cefoperazone and sulbactam sodium) were implanted into the debrided site to reconstruct the anterior column and to control the infection. Patients were treated with intravenous broad-spectrum antibiotics for 6-8 weeks followed by oral antibiotics for a total period of 3 months. The mean duration of follow-up was 25.2 ± 8.1 months (range 12 to 36 months).

Results showed there was no recurrence of infection during study period and surgical incisions healed without chronic infection or fistula formation. All patients experienced significant improvement in constitutional symptoms and back pain, with early ambulation the day after the surgery. The mean visual analogue scale (VAS) improved from 7.5 to 1.6 (P<0.001) and the Oswestry Disability Index (ODI) score improved from 65% to 10% (P<0.001). Inflammatory markers (ESR and CRP) returned to normal in all patients within 3 months following surgery. New bone growth and solid bone fusion were confirmed in all cases with an average time of 4.6 months (range: 3-6 months). The Cobb angle was significantly improved post-surgery and maintained at final follow-up (P<0.001). No complications related to instrumentation, decompression, or use of calcium sulfate beads were reported. Study limitations include smaller sample size and lack of control arm.

Authors concluded that the posterolateral debridement and percutaneous fixation combined with implantation of antibiotic-loaded calcium sulfate is a safe and effective procedure for spondylodiscitis in terms of infection control, early mobilization and recovery.

Publication
https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-05230-y

Statements

Key Points and Summary prepared by Biocomposites Ltd. The new/unapproved uses of STIMULAN described in this scientific article have not been approved/cleared by the (US) FDA and the safety and effectiveness for the new/unapproved use has not been established.

The (US) FDA approved/cleared use of SIMULAN is available here. These Instructions for Use specify the approved/cleared intended use, indications, contraindications, warnings and precautions.