Hip Arthroplasty With SL Cementless

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04979104

Enrollment

Registered

2021-07-28

Start date

2021-06-08

Completion date

2023-12-11

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Replacement

Keywords

Cementless femoral stem, Hip arthroplasty

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.

Interventions

PROCEDUREHip arthroplasty with SL Cementless

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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;

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026