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

Limacorporate S.p.a1 site in 1 country64 target enrollmentJune 4, 2021

ConditionsHip Arthropathy Orthopedic Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hip Arthropathy
Sponsor: Limacorporate S.p.a
Enrollment: 64
Locations: 1
Primary Endpoint: Revision rate of the femoral component
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 4, 2021

End Date

April 8, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Limacorporate S.p.a

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Functionality evaluation(from baseline to FU 10 Years)
Incidence of device-related adverse events or serious adverse events.(from baseline to FU 10 Years)
Implant stability(from baseline to FU 10 Years)