Hip ReplacementNCT05003739
Hip Arthroplasty With Logica Mirror Femoral Stem
An observational study of Hip Replacement, run by Limacorporate S.p.a at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Replacement
- What is being tested?
- Hip arthroplasty with Logica Mirror femoral stem
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Jun 2021to 10 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Nemocnice Kyjov Hospital (CZ)
Who may be able to join
None listed.
Who cannot join
- Age < 18 years;
- Female patients who are pregnant, nursing, or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hip Replacement
- Being tested
- Hip arthroplasty with Logica Mirror femoral stem
- Keywords
- Cemented femoral stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip arthroplasty with Logica Mirror femoral stemProcedure or surgery
Total or partial hip arthroplasty with implant of Logica Mirror femoral stem
| Study group | Role | What they receive |
|---|---|---|
| Logica Mirror | Since the trial is not comparative, the only arm implies the use of the investigational device (Logica Mirror femoral stem) Receives: Procedure: Hip arthroplasty with Logica Mirror femoral stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: From preoperative (baseline) to 3 years after surgery
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: From discharge to 3 years after surgery
Survival rate of the implant
Survival rate of the implant (Kaplan-Meier) at 3 years after surgery
Measured: 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).
Measured: From intraoperative to 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start7 Jun 2021
- Primary completion12 Nov 2025
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Limacorporate S.p.aThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003739
- Sponsor's protocol ID
- H-37
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty With Logica Mirror Stem.
- ClinicalTrials.gov ID
- NCT05003739
- Acronym / sponsor ID
- H-37
- Conditions
- Hip Replacement
- Keywords
- Cemented femoral stem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Logica Mirror | – | Procedure: Hip arthroplasty with Logica Mirror femoral stemSince the trial is not comparative, the only arm implies the use of the investigational device (Logica Mirror femoral stem) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Nemocnice Kyjov Hospital (CZ)
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Age < 18 years;
- Female patients who are pregnant, nursing, or planning a pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip arthroplasty with Logica Mirror femoral stemTotal or partial hip arthroplasty with implant of Logica Mirror femoral stem | Procedure or surgery | Logica Mirror |
Primary outcome
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;
5 secondary outcomes
Oxford Hip Score - Functional change
Time frame: From preoperative (baseline) to 3 years after surgery
VAS satisfaction
Time frame: From 6 weeks to 3 years after surgery
Radiographic implant evaluation and stability assessment of Logica Mirror stem
Time frame: From discharge to 3 years after surgery
Survival rate of the implant
Time frame: 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)
Time frame: From intraoperative to 3 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Replacement, run by Limacorporate S.p.a at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score - Functional change (time frame: From preoperative (baseline) to 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.