Hip Arthroplasty With Logica Mirror Femoral Stem

Limacorporate

Status: Active, not recruiting

Conditions: Hip Replacement

Treatments: Procedure: Hip arthroplasty with Logica Mirror femoral stem

Study type: Observational

Funder types: Industry

Identifiers

NCT05003739

H-37

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

62 participants in 1 patient group

Logica Mirror

Description:

Since the trial is not comparative, the only arm implies the use of the investigational device (Logica Mirror femoral stem)

Treatment:

Procedure: Hip arthroplasty with Logica Mirror femoral stem