Hip Arthroplasty With Logica Mirror Femoral Stem

Study Overview
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Brief Summary
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Logica Mirror femoral stem is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect additional evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within three years after the surgery, and thus to assess the short-term performance and safety of this implant.

Official Title
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A Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty With Logica Mirror Stem.

Conditions
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Hip Replacement

Intervention / Treatment
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* Procedure: Hip arthroplasty with Logica Mirror femoral stem


Participation Criteria
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Eligibility Criteria
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All patients that underwent partial or total hip arthroplasty and implanted with LOGICA MIRROR femoral stem between Jan 2010 and Dec 2021 at Nemocnice Kyjov Hospital (CZ) in accordance with the indication for use of the product and site standard of practice. Additional Inclusion criteria: Availability of patients' immediate post-operative radiograph (baseline) and of a number of follow-up x-rays that the Principal Investigator deems sufficient for an effective radiographic implant evaluation and stability assessment; Patient is willing and able to complete additional follow-up evaluations if needed after signing ICF. Exclusion criteria Age < 18 years; Female patients who are pregnant, nursing, or planning a pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The trial is open-label, not randomized, retrospective and longitudinal cohort clinical study. The follow up outcomes of each patient are compared with the baseline measurements of the same subject (preoperative assessment for clinician-based evaluations and patient-reported outcomes; immediate postoperative assessment for the radiographical evaluation)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Logica Mirror<br>Since the trial is not comparative, the only arm implies the use of the investigational device (Logica Mirror femoral stem) | Procedure: Hip arthroplasty with Logica Mirror femoral stem<br>* Total or partial hip arthroplasty with implant of Logica Mirror femoral stem<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score - Functional change between preop and 3 years FU | Functional change in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery. The maximum score of HHS is 100 points. Pain domain contributes 44 points, function 47, ROM 5 and absence of deformity 4 points. Results can be interpreted with the following: Less than 60= failed result; 60 to 69= poor result; 70 to 79= fair; 80 to 90= good; 90 to 100= excellent; | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score - Functional change between preop and 6 weeks FU, 3 months FU, 1 year FU | Functional change in Harris Hip Score between preoperative (baseline) and 6 weeks FU, 3 months FU, 1 year FU; | 6 weeks, 3 months, 1 year | 
| Oxford Hip Score - Functional change between preop and 6 weeks FU, 3 months FU, 1 year FU, 3 years FU | Functional change in Oxford Hip Score between preoperative (baseline) and 6 weeks FU, 3 months FU, 1 year FU, 3 years FU. The OHS is a short 12-item survey. It comprises two domains (pain and function), with six items or questions in each, using the following scoring: each question has been scored between 0 and 4, with 4 being the best outcome, producing overall scores running from 0 to 48, with 48 being the best outcome. The calculation of the total score of OHS is based on this scoring system and the resulted score can be interpreted as follows: less than 27 points= poor; 27 to 33 points= fair; 34 to 41 points= good; 41 to 48 points= excellent | 6 weeks, 3 months, 1 year, 3 years | 
| VAS satisfaction | Functional evaluation of VAS satisfaction at 6 weeks FU, 3 months FU, 1 year FU, 3 years FU; Patient is asked to rate his satisfaction by making a vertical mark on the 100-mm line. The measurement in millimetres is eventually converted to the same number of points ranging from 0 to 100 points | 6 weeks, 3 months, 1 year, 3 years | 
| Radiographic implant evaluation and stability assessment of Logica Mirror stem | Stability assessment of Logica Mirror stem (through radiographic implant evaluation) at the following timepoints: at discharge, 6 weeks, 3 months, 1 year, 3 years. For assessing the stability of the femoral component in a cemented configuration, the presence of radiolucent lines should be recorded both at stem-cement interface and at cement-bone interface. At each postoperative time-point the radiolucencies will be measured in every Gruen zone and graded in accordance to the following classification: None: No evidence of radiolucency mm: Presence of 1 mm-width radiolucent lines mm: Presence of 2 mm-width radiolucent lines > 2 mm: Presence of radiolucent lines wider than 2 mm | At discharge, 6 weeks, 3 months, 1 year, 3 years | 
| Survival rate of the implant at 3 years after surgery | Survival rate of the implant (Kaplan-Meier) at 3 years after surgery | 3 years | 
| Safety profile of Logica Mirror by recording adverse events (AE), serious adverse events (SAE), device deficiency (DD), adverse device effect (ADE), serious adverse device effect (SADE) | Incidence of device-related adverse events( AE), serious adverse events (SAE), device deficiency (DD), adverse device effect (ADE), serious adverse device effect (SADE) at every follow-up (intraoperative, immediate post-operative, 6 weeks, 3 months, 1 year, 3 years). | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cemented femoral stem