Hip Arthroplasty with SL Cementless

Limacorporate

Status: Completed

Conditions: Hip Replacement

Treatments: Procedure: Hip arthroplasty with SL Cementless

Study type: Observational

Funder types: Industry

Identifiers

NCT04979104

H-36

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

SL Cementless

Description:

Since the trial is not comparative, the only arm implies the use of the investigational device (SL cementless femoral stem)

Treatment:

Procedure: Hip arthroplasty with SL Cementless