Authors: Cierny G, DiPasquale D, REOrthopaedics, Inc.San Diego, CA
Title: Comparing OsteoSet and Stimulan Antibiotic-loaded, Calcium Sulfate Beads in the Management of Deep, Musculoskeletal Infections.
Purpose: To evaluate the use and bio-compatibility of two, different CaSO4 antibiotic delivery systems in the treatment of chronic infection.
Methods: 17 consecutive patients with chronic osteomyelitis received 24 implantations of CaSO4 antibiotic beads in the course of treatment: 10 implants, Stimulan (BioComposites, NC); 14 implants, OsteoSet (Wright Medical, Memphis). The implants were used alone or in combination with PMMA-Ab spacers to fill a residual dead space at the time of wound closure. Patients were prospectively staged according to the Cierny/Mader classification system. The antibiotics used in the depots were selected to cover all culture isolates. In every instance, the wound was closed in layers and over a closed-suction drain. Patient cohorts were monitored for peri-operative wound-healing disturbances and overall, infection control.
Results: Wound-healing disturbances were documented in 4 of the 24 treatment arms (17%). In both CaS04 groups, antibiotic seroma concentrations remained above pathogen MICs for >3weeks. There were no radiographic or clinical signs of residual beads in either group by 6 weeks post-operative.
The OsteoSet kits were user friendly in the OR and produced a versatile antibiotic bead. Use of OsteoSet was limited due to "set-time" failures when attempting to use many of the antibiotics call for and to meet protocol in our patient population. There were 4 wound-healing disturbances (29%) in the OsteoSet group: one dehiscence; one spontaneous fistula; two impending fistulas. All these occurred in A-hosts(C/M). One patient required an unplanned return to the operating room. Stimulan Kits were difficult to work with and created an inferior bead-product. However, chemical 'composition' of these kits tolerated a wider spectrum of antibiotic combinations without an alteration in "setting" characteristics. This included antifungal and a broad, anaerobic coverage. There were no wound healing disturbances or unplanned surgeries in this group.
Discuassion and Conclusion:
- OsteoSet kits were user friendly produced a more versatile, antibiotic bead.
- Both CaSO4 products yielded an effective vehicle to deliver antibiotics by depot.
- Stimulan offered an important, diverse antibiotic carrying capacity.
- Wound healing disturbances continue to occur with the use of OsteoSet beads.
- To date, no wound healing disturbances have occurred in the Stimulan cohort.