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

NCT ID: NCT06928948

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Prosthesis Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Femur replacement

Reconstruction using the Limb Preservation System™ for segmental resection of the distal femur.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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29BRC24.0294 - RESIF

Identifier Type: -

Identifier Source: org_study_id

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