Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SL Cementless | Since the trial is not comparative, the only arm implies the use of the investigational device (SL cementless femoral stem) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip arthroplasty with SL Cementless | Procedure | Total or partial hip arthroplasty with implant of SL cementless femoral stem. |
|
| 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 |
| 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 |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients from Nemocnice Kyjov Hospital (CZ)
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Kyjov Hospital | Kyjov | CZ Republic | Czechia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |