Hip Arthroplasty with SL Cementless

March 5, 2025 updated by: Limacorporate S.p.a

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
    • CZ Republic
      • Kyjov, CZ Republic, Czech Republic
        • Nemocnice Kyjov Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients from Nemocnice Kyjov Hospital (CZ)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SL Cementless
Since the trial is not comparative, the only arm implies the use of the investigational device (SL cementless femoral stem)
Procedure: Hip arthroplasty with SL Cementless
Total or partial hip arthroplasty with implant of SL cementless femoral stem.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years FU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks, 3 months, 1 year, 3 years after surgery
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;
6 weeks, 3 months, 1 year, 3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limacorporate S.p.a

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

December 11, 2023

Study Completion (Actual)

December 11, 2023

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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