Revision LR Femoral Stem for Hip Replacement

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810584
• Other study ID #: H-32
• Status: Completed
• Start date: June 4, 2021
• Est. completion date: April 8, 2024

Study information

• Verified date: April 2024
• Source: Limacorporate S.p.a
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 8, 2024
• Est. primary completion date: April 8, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Device:
• Revision LR femoral stem
Revision LR is a modular femoral stem used for hip replacement

Locations

Country	Name	City	State
Italy	A.S.S.T Spedali Civili di Brescia	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Italy, 

Outcome

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