NCT04121585

Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SL-PLUS™ stem within an observation study Study design: prospective, multicenter, observational, non-comparative study Study population: 240 consecutive cases (HA-coated implants), 60 cases per study site Intervention (if applicable): Implantation of a total hip endoprosthesis Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaires HOOS and EQ-5D Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.

Conditions

• Primary Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	Total Hip Arthroplasty	Total Hip Arthroplasty using the SL-PLUS™ hydroxylapatite coated cement free hip stem

Timeline

• Start date: 2009-06-12
• Primary completion: 2020-10-27
• Completion: 2020-10-27
• First posted: 2019-10-10
• Last updated: 2023-06-01

Locations

2 sites across 1 country: Austria