Hip Replacement Clinical Trial
Official title:
A Post-market Study Evaluating Clinical and Radiographic Early Outcomes pf Hip Arthroplasty With SL Cementless Stem.
NCT number | NCT04979104 |
Other study ID # | H-36 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 8, 2021 |
Est. completion date | December 11, 2023 |
Verified date | February 2024 |
Source | Limacorporate S.p.a |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 11, 2023 |
Est. primary completion date | December 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Nemocnice Kyjov Hospital | Kyjov | CZ Republic |
Lead Sponsor | Collaborator |
---|---|
Limacorporate S.p.a |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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