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Enrolling by invitation NCT06928948

Medium-term Results of the LPS™ System for Segmental Resection of the Distal Femur, a Multicenter Retrospective Study (RESIF)

Observational Prosthesis Failure

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
The protocol lists: Femur replacement.
Who it may be relevant to
Registry conditions: Prosthesis Failure. Basic parameters: No limits · 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 →
Official title

Medium-term Results of the LPS™ System for Segmental Resection of the Distal Femur, a Multicenter Retrospective Study.

Overview

The reconstruction of the distal femur using modular systems has become increasingly popular over the years, surpassing primary arthrodesis or amputation. Despite the significant advantages of using megaprostheses, complications are not uncommon. Although the Limb Preservation System™ (LPS™, DePuy Synthes; Warsaw, USA) is one of the most widely used megaprostheses in the French market, there is currently no national evaluation of this system, and only two studies have been conducted worldwide. The aim of our study is to present the mid-term survival rates of the LPS™ implant in order to answer three main questions: 1. What are the overall outcomes of the LPS™ system in distal femur replacement? 2. What factors are associated with a reduced survival rate of the implant? 3. What is the cumulative risk of complications according to Henderson's classification? The secondary objective is to analyze the occurrence of specific failures, providing insights for potential improvements in the design and use of the LPS™ implant.

Interventions

  • Procedure Femur replacement
    Reconstruction using the Limb Preservation System™ for segmental resection of the distal femur.

Primary outcome measures

  • LPS stent failure [Time frame: From enrollment to last consultation]
Secondary outcome measures (2)
  • complications of the LPS stent [Time frame: From enrollment to last consultation]
  • Surgical revision of the LPS stent [Time frame: From enrollment to last consultation]

Eligibility criteria

Inclusion criteria

\- Patients who underwent distal femoral reconstruction using the LPS system.

Exclusion criteria

  • Lost to follow-up before 3 months.
  • Associated tibial reconstruction using the LPS system.
  • Total femoral reconstruction using the LPS system.

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 Brest — Brest

Identifiers

NCT: NCT06928948 · 29BRC24.0294 - RESIF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗