Revision LR Femoral Stem for Hip Replacement | NCT05810584

Studies
Revision LR Femoral Stem for Hip Replacement

NCT05810584

Sponsor

Limacorporate S.p.a

Status

Completed

Last Update Posted

Apr 19, 2024Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Hip Arthropathy
Orthopedic Disorder

Interventions

Revision LR femoral stem

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2021Actual

Primary Completion Date

Apr 8, 2024Actual

Completion Date

Apr 8, 2024Actual

First Submitted Date

Mar 31, 2023

First Submission Date that Met QC Criteria

Mar 31, 2023

First Posted Date

Apr 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2024

Last Update Posted Date

Apr 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Name	Type	Description	Arm Group Labels	Other Names
Revision LR femoral stem	Device	Revision LR is a modular femoral stem used for hip replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Functionality evaluation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample