Clinical trial · Observational
Prospective Evaluation of Adler Laboratory's Massive Prosthetic Implants in Oncological and Non-oncological Situations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Femur reconstruction Proximal (PFR)/Distal (DFR)/Total (TFR), Proximal Tibia (PTR), Custom implants
- description
- Massive prosthetic reconstruction using the Pantheon prosthesis from Adler Laboratories. The prostheses are: * Proximal Femur Recontruction (PFR) * Distal Femur Reconstruction (DFR) * Proximal Tibia Reconstruction (PTR) * Total Femur Reconstruction (TFR) * Custom implants
Primary outcomes (1)
- measure
- Evaluation of prosthesis survival
- timeFrame
- 1 year, 2 years and 5 years post-operative
- description
- 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 outcomes (4)
- measure
- Evaluation of functional outcomes
- timeFrame
- 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available