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Enrolling by Invitation

NCT Number: NCT06928948

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

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.

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Key information

Conditions

Prosthesis Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Femur replacement

Procedure

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

Primary outcomes

  1. LPS stent failure

    Time frame: From enrollment to last consultation

    Failure will be defined as the replacement of the femoral anchorage or amputation.

Secondary outcomes

  1. complications of the LPS stent

    Time frame: From enrollment to last consultation

    Complications will be defined according to Henderson's classification.

  2. Surgical revision of the LPS stent

    Time frame: From enrollment to last consultation

    Any reoperation on the knee after the LPS one

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: RESIF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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