Hip Arthroplasty With Logica Mirror Femoral Stem

Hip Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003739
• Other study ID #: H-37
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: Limacorporate S.p.a
• Contact: Federica Azzimonti
• Phone: +39 377 5450940
• Email: federica.azzimonti[@]limacorporate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and adverse event records within three years after the surgery, and thus to assess the short-term performance and safety of this implant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Replacement

Intervention

Procedure:
• Hip arthroplasty with Logica Mirror femoral stem
Total or partial hip arthroplasty with implant of Logica Mirror femoral stem

Locations

Country	Name	City	State
Czechia	Nemocnice Kyjov Hospital	Kyjov	CZ Republic

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score - Functional change between preop and 3 years FU	Functional change in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery.; 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;	3 years
Secondary	Harris Hip Score - Functional change between preop and 6 weeks FU, 3 months FU, 1 year FU	Functional change in Harris Hip Score between preoperative (baseline) and 6 weeks FU, 3 months FU, 1 year FU;	6 weeks, 3 months, 1 year
Secondary	Oxford Hip Score - Functional change between preop and 6 weeks FU, 3 months FU, 1 year FU, 3 years FU	Functional change in Oxford Hip Score between preoperative (baseline) and 6 weeks FU, 3 months FU, 1 year FU, 3 years FU. 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	6 weeks, 3 months, 1 year, 3 years
Secondary	VAS satisfaction	Functional evaluation of VAS satisfaction at 6 weeks FU, 3 months FU, 1 year FU, 3 years FU; 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	6 weeks, 3 months, 1 year, 3 years
Secondary	Radiographic implant evaluation and stability assessment of Logica Mirror stem	Stability assessment of Logica Mirror stem (through radiographic implant evaluation) at the following timepoints: at discharge, 6 weeks, 3 months, 1 year, 3 years.; 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	At discharge, 6 weeks, 3 months, 1 year, 3 years
Secondary	Survival rate of the implant at 3 years after surgery	Survival rate of the implant (Kaplan-Meier) at 3 years after surgery	3 years
Secondary	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) at every follow-up (intraoperative, immediate post-operative, 6 weeks, 3 months, 1 year, 3 years).	up to 3 years