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

NCT06928948 | Enrolling By Invitation

• 1 other identifier: 29BRC24.0294 - RESIF
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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. 1.What are the overall outcomes of the LPS™ system in distal femur replacement?
2. 2.What factors are associated with a reduced survival rate of the implant?
3. 3.What is the cumulative risk of complications according to Henderson's classification?

Conditions

Prosthesis Failure

Keywords

megaprosthesis; knee replacement

Outcome Measures

Primary Outcomes (1)

• LPS stent failure

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

  From enrollment to last consultation

Secondary Outcomes (2)

• complications of the LPS stent

  From enrollment to last consultation

• Surgical revision of the LPS stent

  From enrollment to last consultation

Interventions

Femur replacement PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: April 15, 2025
• Study Start: November 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 15, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

FR (1)