Revision LR Femoral Stem for Hip Replacement

NCT05810584 | Completed

• 1 other identifier: H-32
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Hip Arthropathy; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• Revision rate of the femoral component

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

  from baseline to FU 10 Years

Secondary Outcomes (3)

• Implant stability

  from baseline to FU 10 Years

• Functionality evaluation

  from baseline to FU 10 Years

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

  from baseline to FU 10 Years

Interventions

Revision LR femoral stem DEVICE

Revision LR is a modular femoral stem used for hip replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

A.S.S.T Spedali Civili di Brescia

Brescia, Italy

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 12, 2023
• Study Start: June 4, 2021
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

IT (1)