Revision LR Femoral Stem for Hip Replacement

April 18, 2024 updated by: Limacorporate S.p.a

A Retrospective and Prospective Clinical Study Evaluating Safety and Performance of Revision LR Stem in Total Hip Arthroplasty (THA)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy
        • A.S.S.T Spedali Civili di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revision rate of the femoral component
Time Frame: from baseline to FU 10 Years
Revision rate of the femoral component for aseptic loosening, not resultant from a tumor recurrence.
from baseline to FU 10 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: from baseline to FU 10 Years
Implant stability via radiographic assessment of the X-rays at followup, using immediate postoperative X-rays as baseline;
from baseline to FU 10 Years
Functionality evaluation
Time Frame: from baseline to FU 10 Years
Functionality of the patients measured via Harris Hip Score up to last available FU
from baseline to FU 10 Years
Incidence of device-related adverse events or serious adverse events.
Time Frame: from baseline to FU 10 Years
Incidence of device-related adverse events or serious adverse events
from baseline to FU 10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limacorporate S.p.a

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2021

Primary Completion (Actual)

April 8, 2024

Study Completion (Actual)

April 8, 2024

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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