Hip Arthroplasty With SL Cementless

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Replacement

Intervention / Treatment
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* Procedure: Hip arthroplasty with SL Cementless


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The trial is open-label, not randomized, retrospective and longitudinal cohort clinical study. The follow up outcomes of each patient are compared with the baseline measurements of the same subject (preoperative assessment for clinician-based evaluations and patient-reported outcomes; immediate postoperative assessment for the radiographical evaluation)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SL Cementless<br>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<br>* Total or partial hip arthroplasty with implant of SL cementless femoral stem.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cementless femoral stem, Hip arthroplasty