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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Survival, Kaplan Meier | Survival rate: Rate of hip implants in situ after 10 years of follow-up. | up to 10 years after implantation |
| Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge | Rate of hip implant experiencing intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge. Rate of hip implants with Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects | up to patient's discharge from the hospital/clinic (from surgery up to 7 days after surgery) |
| Postoperative AE up to 10 years after the surgery | Rate of hip implants experiencing Postoperative AE up to 10 years after the surgery Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects | up to 10 years after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration. | Rate of hip implants with radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration. | up to 10 years after implantation |
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Inclusion Criteria:
Exclusion Criteria:
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135 consecutive cases (uncoated SL-PLUS® MIA implants)
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| Name | Affiliation | Role |
|---|---|---|
| Vinzenz v. Auersperg, Prim. Dr. | Orthopädie LKH Steyr | Principal Investigator |
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| Harris Hip Score |
The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty.The score considers information on pain, function and range of motion. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome. |
| up to 10 years after implantation |