Hip Arthroplasty With Logica Mirror Femoral Stem

NCT05003739 | Active Not Recruiting

• 1 other identifier: H-37
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Replacement

Keywords

Cemented femoral stem

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Oxford Hip Score - Functional change

  From preoperative (baseline) to 3 years after surgery

• VAS satisfaction

  From 6 weeks to 3 years after surgery

• Radiographic implant evaluation and stability assessment of Logica Mirror stem

  From discharge to 3 years after surgery

• Survival rate of the implant

  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)

  From intraoperative to 3 years after surgery

Study Arms (1)

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

Interventions

Hip arthroplasty with Logica Mirror femoral stem PROCEDURE

Total or partial hip arthroplasty with implant of Logica Mirror femoral stem

Logica Mirror

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from Nemocnice Kyjov Hospital (CZ)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years;
• Female patients who are pregnant, nursing, or planning a pregnancy

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Nemocnice Kyjov Hospital

Kyjov, CZ Republic, Czechia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 12, 2021
• Study Start: June 7, 2021
• Primary Completion: November 12, 2025
• Study Completion: February 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)