Prosthesis FailureRESIFNCT06928948
Medium-term Results of the LPS™ System for Segmental Resection of the Distal Femur, a Multicenter Retrospective Study (RESIF)
An observational study of Prosthesis Failure, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prosthesis Failure
- What is being tested?
- Femur replacement
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who underwent distal femoral reconstruction using the LPS system.
Who cannot join
- Lost to follow-up before 3 months.
- Associated tibial reconstruction using the LPS system.
- Total femoral reconstruction using the LPS system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- What are the overall outcomes of the LPS™ system in distal femur replacement?
- What factors are associated with a reduced survival rate of the implant?
- 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.
- Conditions
- Prosthesis Failure
- Being tested
- Femur replacement
- Keywords
- megaprosthesis, knee replacement
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femur replacementProcedure or surgery
Reconstruction using the Limb Preservation System™ for segmental resection of the distal femur.
What is being measured
The primary outcome is the main question the study is designed to answer.
LPS stent failure
Failure will be defined as the replacement of the femoral anchorage or amputation.
Measured: From enrollment to last consultation
Secondary outcomes (2)
complications of the LPS stent
Complications will be defined according to Henderson's classification.
Measured: From enrollment to last consultation
Surgical revision of the LPS stent
Any reoperation on the knee after the LPS one
Measured: From enrollment to last consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Nov 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928948
- Sponsor's protocol ID
- 29BRC24.0294 - RESIF
- Acronym
- RESIF
- Status last verified
- Oct 2024
- First submitted
- 13 Feb 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-term Results of the LPS™ System for Segmental Resection of the Distal Femur, a Multicenter Retrospective Study.
- ClinicalTrials.gov ID
- NCT06928948
- Acronym / sponsor ID
- RESIF / 29BRC24.0294 - RESIF
- Conditions
- Prosthesis Failure
- Keywords
- megaprosthesis, knee replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the overall outcomes of the LPS™ system in distal femur replacement?
- What factors are associated with a reduced survival rate of the implant?
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who underwent distal femoral reconstruction using the LPS system.
Key exclusion criteria (3 listed)
- Lost to follow-up before 3 months.
- Associated tibial reconstruction using the LPS system.
- Total femoral reconstruction using the LPS system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femur replacementReconstruction using the Limb Preservation System™ for segmental resection of the distal femur. | Procedure or surgery | – |
Primary outcome
LPS stent failure
Time frame: From enrollment to last consultation
Failure will be defined as the replacement of the femoral anchorage or amputation.
2 secondary outcomes
complications of the LPS stent
Time frame: From enrollment to last consultation
Surgical revision of the LPS stent
Time frame: From enrollment to last consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthesis Failure, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LPS stent failure (time frame: From enrollment to last consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.