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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prosthesis Failure
• Intervention / Treatment: Procedure: Femur replacement

• Study Type: Observational
• Enrollment (Estimated): 77

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The institutional databases of university hospitals belonging to the HugOrtho network (Hôpitaux Universitaires du Grand Ouest) will be examined to identify patients who will have undergone reconstruction using the Limb Preservation System™ (LPS™, DePuy Synthes; Warsaw, USA) for segmental resection of the distal femur, regardless of the indication.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LPS stent failure	Failure will be defined as the replacement of the femoral anchorage or amputation.	From enrollment to last consultation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: knee replacement; megaprosthesis
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Prosthesis Failure
• Other Study ID Numbers: 29BRC24.0294 - RESIF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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