NCT04036071

Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 165 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SLPLUS ™ MIA stem within an observation study Study design: prospective, multicenter, observational, noncomparative study Study population: 300 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, HOOS Score, EQ-5D, implant-related complications, revisions 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. In addition, study patients are asked to provide information on their general state of health and the condition of their hip in two questionnaires. These clinical and radiological follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the direct 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™ MIA cement free hip stem

Timeline

• Start date: 2009-05-15
• Primary completion: 2020-10-27
• Completion: 2020-10-27
• First posted: 2019-07-29
• Last updated: 2023-06-01

Locations

3 sites across 1 country: Austria