Revision LR Femoral Stem for Hip Replacement

NCT ID: NCT05810584

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-04

Study Completion Date

2024-04-08

Brief Summary

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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

Detailed Description

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Conditions

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Hip Arthropathy Orthopedic Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Revision LR femoral stem

Revision LR is a modular femoral stem used for hip replacement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Limacorporate S.p.a

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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A.S.S.T Spedali Civili di Brescia

Brescia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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H-32

Identifier Type: -

Identifier Source: org_study_id

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