Massive prostheses are the standard treatment for extensive bone loss, whether caused by cancer or other factors (complex fractures, multiple revisions, infections). The emergence of modular systems such as the Pantheon range provides rapid restoration of function and precise intraoperative adaptation to anatomical constraints and specific bone loss characteristics. The Pantheon range also offers an innovative intramedullary ring system that promotes osseointegration and potentially long-term mechanical stability of implants. However, few studies have evaluated its clinical efficacy. In this context, a prospective cohort study is warranted in order to obtain robust data on implant survival, patient quality of life and predictors of medium- and long-term complications.
The IMPULSION study is an observational study. The primary objective is to evaluate prosthesis survival within 5 years post-operatively. The secondary objectives are: to evaluate functional outcomes, quality of life, the occurrence of complications, and the osseointegration of the intramedullary ring. Patients are included during the consultation to plan the surgery. Following surgery, the patient is followed up at 1 year, 2 years and 5 years post-operatively.
Study Type
OBSERVATIONAL
Enrollment
375
Evaluation of prosthesis survival
The survival of the prosthesis is defined by the absence of revision surgery. This objective will be analysed in subgroups according to the type of implant used (PFR, DFR, PTR, TFR) or other implants (hybrid connector, custom-made).
Time frame: 1 year, 2 years and 5 years post-operative
Evaluation of functional outcomes
MSTS score collected at inclusion, then post-operatively: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) As with the main objective, these objectives will be analysed in subgroups according to the type of implant used (PFR,DFR,PTR,TFR) or other implants (hybrid connector, custom-made).
Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of quality of life
EQ-5D-5L auto-questionnaire at inclusion, then post-operatively: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) As with the main objective, these objectives will be analysed in subgroups according to the type of implant used (PFR,DFR,PTR,TFR) or other implants (hybrid connector, custom-made).
Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of complications occurring within 5 years post-operatively
Complications coded according to the Henderson classification within 5 years post-operatively As with the main objective, these objectives will be analysed in subgroups according to the type of implant used (PFR,DFR,PTR,TFR) or other implants (hybrid connector, custom-made).
Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of osseointegration of the intramedullary ring
Radiographic analysis 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) (4 cortical images on front and profile views): osseointegration Yes/No/Don't know As with the main objective, these objectives will be analysed in subgroups according to the type of implant used (PFR,DFR,PTR,TFR) or other implants (hybrid connector, custom-made).
Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
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