CClinicalTrials.gg
CompletedNCT05810584Updated Apr 19, 2024

Revision LR Femoral Stem for Hip Replacement

An observational study in Hip Arthropathy and Orthopedic Disorder, sponsored by Limacorporate S.p.a. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Limacorporate S.p.a · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
64
Ages
18 Years and older
Sex
All
01

Study summary

This is a post-market, monocentric Retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of Revision LR femoral stem

02

Conditions studied

  • Hip Arthropathy
  • Orthopedic Disorder
03

In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's enrollment of 64 is below the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Limacorporate S.p.a is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who underwent a hip arthroplasty with Revision LR stem at Spedali Civili (Brescia) from 1st January 2012 will be screened for the retrospective part of the study. Patients who require a hip arthroplasty with a large femur resection will be screened for the prospective part of the study.

Inclusion criteria

  • Males and females of any race
  • Age ≥ 18 years old
  • A diagnosis or condition in the target hip of one or more of the following: Primary tumors or metastasis and relative outcomes; Advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;Fracture or avascular necrosis; Congenital or acquired deformity; Failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty; Epiphyseal region general trauma, Willingness to comply with prescribed rehabilitation and study evaluation and ability to return for follow-up visits
  • Signed study-specific Informed Consent Form

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic infections, local or systemic infections,
  • Septicaemia
  • Persistent acute or chronic osteomyelitis
  • Serious muscular, neurological or vascular diseases affecting the concerned limb
  • Mass higher than 60 kg
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
64 participants (actual)
Patient registry
No

Interventions

  • DeviceRevision LR femoral stem

    Revision LR is a modular femoral stem used for hip replacement

06

What researchers measure

Primary outcomes

  1. Revision rate of the femoral component

    Revision rate of the femoral component for aseptic loosening, not resultant from a tumor recurrence.

    Time frame: from baseline to FU 10 Years

Secondary outcomes

  1. Implant stability

    Implant stability via radiographic assessment of the X-rays at followup, using immediate postoperative X-rays as baseline;

    Time frame: from baseline to FU 10 Years

  2. Functionality evaluation

    Functionality of the patients measured via Harris Hip Score up to last available FU

    Time frame: from baseline to FU 10 Years

  3. Incidence of device-related adverse events or serious adverse events.

    Incidence of device-related adverse events or serious adverse events

    Time frame: from baseline to FU 10 Years

07

Study locations

1 site
  • A.S.S.T Spedali Civili di Brescia
    Brescia, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05810584
Lead sponsor
Limacorporate S.p.a
Responsible party
Sponsor
First posted
Apr 12, 2023
Start date
Jun 4, 2021
Primary completion
Apr 8, 2024
Completion
Apr 8, 2024
Last update
Apr 19, 2024

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion