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Completed

NCT Number: NCT04979104

Hip Arthroplasty With SL Cementless

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.

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Key information

Conditions

Hip Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nemocnice Kyjov Hospital

Kyjov, CZ Republic, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip arthroplasty with SL Cementless

Procedure

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

Primary outcomes

  1. Implant radiographic stability

    Time frame: 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 outcomes

  1. Clinical outcomes

    Time frame: 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

  2. Implant safety profile

    Time frame: 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;

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2021
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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