Transcutaneous osseointegrated prosthetic systems after major amputation of the lower extremity A retrospective 3-year analysis

Introduction Transcutaneous osseointegrated prosthetic systems (TOPS) are an established optional procedure for the prosthetic treatment of amputations. Under the term endo-exo-prosthesis (EEP), the endosteal adapted exo-prosthesis (Dr. Grundei (R)) is currently used as the only standard prosthesis for clinical application in Germany. The prosthetic treatment with EEP involves a two-stage surgical procedure. In a first surgical step, the endo-fixed stem is implanted into the bone; in a second operation, approx. 2-6 weeks later, the skin/soft tissue stoma is created, through which the exoprosthetic components can be coupled transcutaneously. Aim The aim of this manuscript was to retrospectively collect descriptive 3-year statistics (2017-2019) from clinical follow-ups and to analyze them with regard to possible effects of TOPS on the mobility level measured by k-levels. In addition, a brief description of the current standard of care in Germany regarding TOPS will be given. Methods All patients who underwent EEP after major amputation from February 2017 to December 2019 (n = 72, with 76 implants) were included in this study. The data of the EEP patients were collected in standardized follow-ups. K-levels were compared preoperatively to 6 months postoperatively. Results A total of N = 72 patients (N = 76 implantations) was analyzed in the described period. The main cause of amputations was trauma (68.9%). Main complications were myofascial complaints. Implant loosening and deep infections were observed in two cases (2.7%) during this period. Stoma problems occurred with a 3-year average of 25.7%. In terms of K-levels, there was a high significant increase from preoperative 1.8 +/- 0.8 to 3.0 +/- 0.4 after a 6-month period. Conclusion TOPS is an established optional procedure for the treatment of limb loss. In Germany, only one implant is currently regularly implanted (endo-exo prosthesis), and the restoration is currently focused on the lower limb. The restoration of patients with major amputation of the lower extremity by means of TOPS can lead to an increase in mobility and, thus, to an increase in daily activities and participation in daily living.