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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.
Primary Total Hip Arthroplasty
Total Hip Arthroplasty
Orthopädie LKH Steyr
Active, not recruiting
Smith & Nephew, Inc.
Published on BioPortfolio: 2019-10-16T10:39:39-0400
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Partial or total replacement of a joint.
Partial or total replacement of one or more FINGERS, or a FINGER JOINT.
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Surgical reconstruction of a joint to relieve pain or restore motion.
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