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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04979104
Other study ID # H-36
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2021
Est. completion date December 11, 2023

Study information

Verified date February 2024
Source Limacorporate S.p.a
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 11, 2023
Est. primary completion date December 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hip arthroplasty with SL Cementless
Total or partial hip arthroplasty with implant of SL cementless 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 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. 3 years FU
Secondary 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 6 weeks, 3 months, 1 year, 3 years after surgery
Secondary 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; 6 weeks, 3 months, 1 year, 3 years after surgery
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