Hip Arthroplasty With Logica Mirror Femoral Stem

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Replacement
• Intervention / Treatment: Procedure: Hip arthroplasty with Logica Mirror femoral stem

• Study Type: Observational
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • CZ Republic
    • Kyjov, CZ Republic, Czechia
      • Nemocnice Kyjov Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients from Nemocnice Kyjov Hospital (CZ)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Logica Mirror; 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; Total or partial hip arthroplasty with implant of Logica Mirror femoral stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score - Functional change	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;	From preoperative (baseline) to 3 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Hip Score - Functional change	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= excellent	From preoperative (baseline) to 3 years after surgery
VAS satisfaction	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 points	From 6 weeks to 3 years after surgery
Radiographic implant evaluation and stability assessment of Logica Mirror stem	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; 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	From discharge to 3 years after surgery
Survival rate of the implant	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).	From intraoperative to 3 years after surgery

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): November 12, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cemented femoral stem
• Other Study ID Numbers: H-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No