Hip Arthroplasty With SL Cementless

Hip Replacement Clinical Trial

Official title:

A Post-market Study Evaluating Clinical and Radiographic Early Outcomes pf Hip Arthroplasty With SL Cementless Stem.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979104
• Other study ID #: H-36
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hip Replacement

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