Hip Arthroplasty With SL Cementless

NCT04979104 | Completed

• 1 other identifier: H-36
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Replacement

Keywords

Cementless femoral stem; Hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical outcomes

  6 weeks, 3 months, 1 year, 3 years after surgery

• Implant safety profile

  6 weeks, 3 months, 1 year, 3 years after surgery

Study Arms (1)

SL Cementless

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

Interventions

Hip arthroplasty with SL Cementless PROCEDURE

Total or partial hip arthroplasty with implant of SL cementless femoral stem.

SL Cementless

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from Nemocnice Kyjov Hospital (CZ)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Age \< 18 years;
• Female patients who are pregnant, nursing, or planning a pregnancy

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Nemocnice Kyjov Hospital

Kyjov, CZ Republic, Czechia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 28, 2021
• Study Start: June 8, 2021
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)