Hip Arthroplasty With SL Cementless

Limacorporate S.p.a60 enrolled

Overview

The study aims to evaluate the clinical, radiographical and patient-reported outcomes measurements up 3 years FU and to assess the survivorship of SL Cementless Stem after partial or total hip arthroplasty.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hip Replacement

Interventions

Hip arthroplasty with SL CementlessPROCEDURE

Total or partial hip arthroplasty with implant of SL cementless femoral stem.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: All patients that underwent to partial or total hip arthroplasty and implanted with SL cementless stem between Jan 2010 and Jan 2020 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

Locations (1)

Nemocnice Kyjov Hospital

Kyjov, CZ Republic, Czechia

Outcomes

Primary Outcomes

Implant radiographic stability

Radiographic implant evaluation and stability assessment of the SL Cementless Stem on collected radiographs as per clinical practice during hospitalization and routine visits.

Time frame: 3 years FU

Secondary Outcomes

Clinical outcomes

Assessment of the clinical evaluation of the SL Cemetless Stem used in real life settings over a period of 3 years through PROMs if available and medical evaluation

Time frame: 6 weeks, 3 months, 1 year, 3 years after surgery

Implant safety profile

Incidence, type and severity of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effect (ADEs), Serious Adverse Device Effects (SADEs) at intraoperatively/discharge, 6 weeks, 3 months, 1 year, 3 years after the implant;

Time frame: 6 weeks, 3 months, 1 year, 3 years after surgery

Data from ClinicalTrials.gov

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