ULTRATHIN SILVER-POLYSILOXANE-COATED PLATES FOR REVISION OF INFECTED FEMORAL NONUNION: FIRST RESULTS

Aim

Aim of this study was to establish the first clinical results after implantation of ultrathin silver-polysiloxane-coated₁ plates in the treatment of infected non-union of the femoral shaft.

Method

As part of the REFECT study, a prospective, non-interventional analysis was conducted encompassing all patients who received internal stabilization with a silver-coated₁ plate from 01/2023 to 09/2024 as part of the treatment for infected non-union of the femur. Standardized clinical follow-ups including PROMs (WOMAC-Index, LEF-S, EQ-5D, VAS) and X-rays were performed 3, 6, 12 (and 24) months postoperatively.

For comparison, a retrospective analysis of 76 patients with infected femoral non-union, who had received a stabilization with an uncoated plate in the past 10 years, was performed.

Results

The mean follow-up of the 8 included patients (mean bone defect: 3.6 cm) was 9 months (as of 04/24). Multiresistant bacteria were found in the intraoperative samples of 5 patients. The concentration of silver ions in blood serum reached a maximum of 0.014 mg/l in the laboratory controls. All patients showed a positive healing process with no sign of re-infection and no adverse procedure-associated events. Full weight bearing was achieved after an average of 4 months (n=6) with improved WOMAC-, LEF-S-, EQ-5D and VAS-score at 1-year FU. In the reference group (uncoated, mean FU: 3.5 years), there was a re-infection rate of 25 %, mostly in the first 2 years. Difficult-to-treat bacteria were detected in 22%, multiresistant Staph. epidermidis in 28% of cases.

Conclusions

1. -

   The silver-coated₁ implants showed good biocompatibility with no evidence of procedure-associated complications.

2. -

   The use of silver-coated₁ implants could reduce the risk of re-infection.

3. -

   Further clinical data with longer follow-up are needed to assess the long-term value of the procedure.