Prospective Evaluation of Adler Laboratory's Massive Prosthetic Implants in Oncological and Non-oncological Situations (IMPULSION)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic)

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.

• Study Type: Observational
• Enrollment (Estimated): 375

Contacts and Locations

• Study Contact: Name: Vincent CRENN, PU-PH; Phone Number: +33 2 44 76 80 58; Email: Vincent.Crenn@univ-nantes.fr

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes
    • Contact: Vincent CRENN, PU-PH; Phone Number: 02 40 08 48 25; Email: vincent.crenn@chu-nantes.fr
    • Contact: Peggy Ageneau; Phone Number: 02 40 08 48 54; Email: peggy.ageneau@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population concerns patients with massive bone loss, because of oncological or non-oncological issue. Patients have 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 Minors aged 15 and over may be included in the study, with no maximum age limit. Patient who has been informed about the study and doesn't object to participating.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Femur reconstruction Proximal (PFR)/Distal (DFR)/Total (TFR), Proximal Tibia (PTR), Custom implants; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year, 2 years and 5 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Vincent CRENN, PU-PH, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): January 30, 2030
• Study Completion (Estimated): January 30, 2036

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Megaprosthesis; pantheon; Massive bone loss
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RC25_0215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No