Antibiotic delivery in orthopedic surgery

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Clinical experience of dissolvable calcium sulfate (STIMULAN) carrier for antibiotic delivery in Orthopedic Surgery

 

Key points

    • ✔ Prospective study including 143 patients undergoing either aseptic or septic orthopedic procedures with inclusion of antibiotic-loaded STIMULAN beads.
    • ✔ Overall success rate was 90.9%. Prophylactic use resulted in a 97% success rate in high-risk patients and 90.9% success rate in previously infected patients. Eradication of established infection was seen in 84.9% of patients.
    • ✔ Postoperative complications in this cohort were infection in 9.1% and wound drainage in 4.9%. No hypercalcemia or heterotopic ossification was reported in this study.
    • ✔ Limitations include the retrospective nature of the study, lack of control group and shorter follow-up period.

 

Summary

In the publication “Clinical experience of dissolvable calcium sulfate (STIMULAN) carrier for antibiotic delivery in Orthopedic Surgery”, Shah, et al. (2025) investigated whether a synthetic calcium sulfate carrier could be utilized as an alternative drug delivery system in patients for prosthetic bone and joint infections. Authors prospectively followed clinical outcomes of 143 patients undergoing orthopedic surgery with the inclusion of antibiotic-loaded calcium sulfate (STIMULAN) beads for either prevention of infection in high-risk patients or treatment of known joint infections.

The study cohort included patients with an established infection (n=66), those that were previously infected (n=11), and those who were high-risk for infection (n=66). Surgical procedures included total knee or hip replacements, aseptic and septic revision arthroplasties, one- and two-stage revisions, debridement, linear exchange procedures, and fracture-related surgeries. Antibiotic-loaded calcium sulfate beads (STIMULAN, vancomycin and tobramycin) were placed in the soft tissue around the joint as well as in the intramedullary canals. The median follow-up for this retrospective study was 30 months (range, 17 to 72 months).

Of the 143 total patients, 130 (90.9%) were free from infection postoperatively. Success rates were 84.9% in patients with an established infection, 90.9% for those previously infected, and 97% for high-risk patients. Postoperative wound drainage was seen in 4.9% and infection in 9.1% of total patients. None of the patients experienced hypercalcemia and no heterotopic ossification was observed radiographically. Limitations include the retrospective nature of the study, lack of control group and shorter follow-up period.

Authors conclude that calcium sulfate beads were safe and effective for local delivery of antibiotics during both septic and aseptic orthopedic surgeries and was effective as a preventative measure in high-risk patients. Authors also report that postoperative infections and complications were lower with use of STIMULAN for antibiotic delivery than was seen previously by them with other antibiotic delivery systems or drugs.

Publication
https://www.dl.begellhouse.com/journals/1bef42082d7a0fdf,4043ec681fa7a41a,6417129f7f6def79.html

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 STIMULAN is available here. These Instructions for Use specify the approved/cleared intended use, indications, contraindications, warnings and precautions.