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Enrolling by invitationNCT06928948RESIFUpdated Apr 15, 2025

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

An observational study in Prosthesis Failure, sponsored by University Hospital, Brest. Enrolling by invitation at 1 site in France. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by University Hospital, Brest · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
77
Sex
All
01

Study 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.

02

Conditions studied

  • Prosthesis Failure

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Keywords

  • megaprosthesis
  • knee replacement
03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 77 is below the median of 119 across 49 observational studies indexed under Prosthesis Failure.

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Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who underwent distal femoral reconstruction using the LPS system.

Exclusion criteria

Exclusion Criteria:

  • Lost to follow-up before 3 months.
  • Associated tibial reconstruction using the LPS system.
  • Total femoral reconstruction using the LPS system.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
77 participants (estimated)
Patient registry
No

Interventions

  • ProcedureFemur replacement

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

06

What researchers measure

Primary outcomes

  1. LPS stent failure

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

    Time frame: From enrollment to last consultation

Secondary outcomes

  1. complications of the LPS stent

    Complications will be defined according to Henderson's classification.

    Time frame: From enrollment to last consultation

  2. Surgical revision of the LPS stent

    Any reoperation on the knee after the LPS one

    Time frame: From enrollment to last consultation

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

Time frame: Data will be available beginning three years and ending fifteen years following the final study report completion

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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2024 (actual). Primary completion is estimated for Jul 2025, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2025
First posted
Apr 15, 2025
StartActual
Nov 1, 2024
Primary completionEst.
Jul 31, 2025
CompletionEst.
Jul 31, 2025
Last update
Apr 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06928948
Responsible party
Sponsor
First posted
Apr 15, 2025
Start date
Nov 1, 2024
Primary completion
Jul 31, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Apr 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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