Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic)
Conditions
Keywords
Megaprosthesis, pantheon, Massive bone loss
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 15 years or older at the time of inclusion * Surgery scheduled at one of the participating centres with an Adler implant from the list below: Implants from the Pantheon prosthesis: Proximal Femur Recontruction (PFR) Distal Femur Reconstruction (DFR) Proximal Tibia Reconstruction (PTR) Total Femur Reconstruction (TFR) Hybrid connector implants Custom-made implants * Follow-up scheduled at one of the participating centres for the duration of the study * Patient who has been informed about the study and does not object to participating In the case of minor patients, the patient's parents will also be informed, and their non-objection will be sought. * Patient affiliated with a Social Security scheme in France.
Exclusion criteria
* Patient or parent of a minor patient who objects to participation in the study and data collection. * Patient deprived of liberty or under legal protection (guardianship or curatorship)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of prosthesis survival | 1 year, 2 years and 5 years post-operative | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of functional outcomes | 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) | 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). |
| Evaluation of quality of life | 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) | 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). |
| Evaluation of complications occurring within 5 years post-operatively | 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) | 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). |
| Evaluation of osseointegration of the intramedullary ring | 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) | 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). |
Countries
France
Contacts
CONTACTVincent CRENN, PU-PH
PRINCIPAL_INVESTIGATORVincent CRENN, PU-PH
Nantes University Hospital
Outcome results
None listed