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

• Conditions: Prosthesis Failure

• Registration Number: NCT06928948
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-01
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LPS stent failure	From enrollment to last consultation	Failure will be defined as the replacement of the femoral anchorage or amputation.

Secondary Outcome Measures

Name	Time	Method
complications of the LPS stent	From enrollment to last consultation	Complications will be defined according to Henderson's classification.
Surgical revision of the LPS stent	From enrollment to last consultation	Any reoperation on the knee after the LPS one

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France