Revision LR Femoral Stem for Hip Replacement

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05810584

Enrollment

Registered

2023-04-12

Start date

2021-06-04

Completion date

2024-04-08

Last updated

2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthropathy, Orthopedic Disorder

Brief 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

Interventions

DEVICERevision LR femoral stem

Revision LR is a modular femoral stem used for hip replacement

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026