Hip Arthroplasty with SL Cementless

Not Applicable

Completed

• Conditions: Hip Replacement
• Interventions: Procedure: Hip arthroplasty with SL Cementless

• Registration Number: NCT04979104
• Lead Sponsor: Limacorporate S.p.a

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-08
• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-28
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SL Cementless	Hip arthroplasty with SL Cementless	Since the trial is not comparative, the only arm implies the use of the investigational device (SL cementless femoral stem)

Primary Outcome Measures

Name	Time	Method
Implant radiographic stability	3 years FU	Radiographic implant evaluation and stability assessment of the SL Cementless Stem on collected radiographs as per clinical practice during hospitalization and routine visits.

Secondary Outcome Measures

Name	Time	Method
Implant safety profile	6 weeks, 3 months, 1 year, 3 years after surgery	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;
Clinical outcomes	6 weeks, 3 months, 1 year, 3 years after surgery	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

Trial Locations

Locations (1)

Nemocnice Kyjov Hospital; 🇨🇿 Kyjov, CZ Republic, Czech Republic