Clinical study of the novel FlexitSystem implant for high tibial open wedge osteotomy

The FlexitSystem implant is a novel implant used in open wedge high tibial osteotomy. A clinical safety study was performed. Retrospectively 50 patients were analyzed who were treated with an open wedge high tibial osteotomy and the new FlexitSystem implant, with a minimal follow-up of one year. Complication rate, radiographic outcomes and implant removal were investigated. One patient underwent a revision surgery because of loss of correction and non-union. The complication rate was 10.0%. No other radiographic complications (screw breakage, implant failure) were found. In 24 patients (48%) the FlexitSystem implant was removed at a mean follow-up of 12.6 months (range 2.6 till 24.0 months). The mean reason was irritation of the implant. The FlexitSystem implant is a clinical safe and stable implant for an open wedge high tibial osteotomy, with a low complication rate. The rate of implant irritation requiring removal remained high.