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

Limacorporate S.p.a1 site in 1 country60 target enrollmentJune 8, 2021

ConditionsHip Replacement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hip Replacement
Sponsor: Limacorporate S.p.a
Enrollment: 60
Locations: 1
Primary Endpoint: Implant radiographic stability
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 8, 2021

End Date

December 11, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Limacorporate S.p.a

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.