NCT07369778

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 375 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic)

Timeline

• Start date: 2026-05-30
• Primary completion: 2030-01-30
• Completion: 2036-01-30
• First posted: 2026-01-27
• Last updated: 2026-04-14

Locations

1 site across 1 country: France