Revision LR Femoral Stem for Hip Replacement

Completed

• Conditions: Hip Arthropathy; Orthopedic Disorder

• Registration Number: NCT05810584
• Lead Sponsor: Limacorporate S.p.a

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-04
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-12
• Status Verified: 2024-04
• Primary Completion: 2024-04-08
• Study Completion: 2024-04-08
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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;

Trial Locations

Locations (1)

A.S.S.T Spedali Civili di Brescia; 🇮🇹 Brescia, Italy