NCT04122157

Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 135 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Summary from initial protocol Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study Study design: prospective, single-center, observational, non-comparative study Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants) 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 questionnaire (WOMAC) 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

Timeline

• Start date: 2007-07-22
• Primary completion: 2019-11-11
• Completion: 2019-11-11
• First posted: 2019-10-10
• Last updated: 2026-01-06