Hip Arthroplasty with Logica Mirror Femoral Stem
- Conditions
- Hip Replacement
- Interventions
- Procedure: Hip arthroplasty with Logica Mirror femoral stem
- Registration Number
- NCT05003739
- Lead Sponsor
- Limacorporate S.p.a
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Logica Mirror Hip arthroplasty with Logica Mirror femoral stem Since the trial is not comparative, the only arm implies the use of the investigational device (Logica Mirror femoral stem)
- Primary Outcome Measures
Name Time Method Harris Hip Score - Functional change From preoperative (baseline) to 3 years after surgery Functional change in Harris Hip Score (HHS). 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;
- Secondary Outcome Measures
Name Time Method Oxford Hip Score - Functional change From preoperative (baseline) to 3 years after surgery Functional change in Oxford Hip Score. 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= excellentVAS satisfaction From 6 weeks to 3 years after surgery Functional evaluation of VAS satisfaction.
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 pointsRadiographic implant evaluation and stability assessment of Logica Mirror stem From discharge to 3 years after surgery Stability assessment of Logica Mirror stem (through radiographic implant evaluation).
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
1. mm: Presence of 1 mm-width radiolucent lines
2. mm: Presence of 2 mm-width radiolucent lines \> 2 mm: Presence of radiolucent lines wider than 2 mmSurvival rate of the implant 3 years Survival rate of the implant (Kaplan-Meier) at 3 years after surgery
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) From intraoperative to 3 years after surgery Incidence of device-related adverse events( AE), serious adverse events (SAE), device deficiency (DD), adverse device effect (ADE), serious adverse device effect (SADE).
Trial Locations
- Locations (1)
Nemocnice Kyjov Hospital
🇨🇿Kyjov, CZ Republic, Czechia