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NCT Number: NCT05003739

Hip Arthroplasty With Logica Mirror Femoral 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nemocnice Kyjov Hospital

Kyjov, CZ Republic, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip arthroplasty with Logica Mirror femoral stem

Procedure

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

Primary outcomes

  1. Harris Hip Score - Functional change

    Time frame: 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 outcomes

  1. Oxford Hip Score - Functional change

    Time frame: 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= excellent

  2. VAS satisfaction

    Time frame: 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 points

  3. Radiographic implant evaluation and stability assessment of Logica Mirror stem

    Time frame: 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

    • 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

  4. Survival rate of the implant

    Time frame: 3 years

    Survival rate of the implant (Kaplan-Meier) at 3 years after surgery

  5. 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)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 12, 2021
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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