Prospective Evaluation of Adler Laboratory's Massive Prosthetic Implants in Oncological and Non-oncological Situations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic). Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Evaluation of prosthesis survival [Time frame: 1 year, 2 years and 5 years post-operative]
Secondary outcome measures (4)
- Evaluation of functional outcomes [Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)]
- Evaluation of quality of life [Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)]
- Evaluation of complications occurring within 5 years post-operatively [Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)]
- Evaluation of osseointegration of the intramedullary ring [Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU de Nantes — Nantes
Identifiers
NCT: NCT07369778 · RC25_0215