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.
Study Type
OBSERVATIONAL
Enrollment
165
Total Hip Arthroplasty using the SL-PLUS™ MIA cement free hip stem
Orthopädische Landesklinik Salzburg
Salzburg, Austria
Orthopädie LKH Steyr
Steyr, Austria
Orthopädisches Krankenhaus Gersthof
Vienna, Austria
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
Time frame: up 10 years after implantation
WOMAC Osteoarthritis Index
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:\[1\] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Time frame: up 10 years after implantation
EuroQuol-5D questionnaire
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal
Time frame: up 10 years after implantation
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge
Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Time frame: 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
Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Time frame: up 10 years after implantation
Survival, Kaplan Meier
Hip implants in situ after 10 years of follow-up
Time frame: up 10 years after implantation
Radiographic changes defined as radiolucent lines,osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.
Time frame: up 10 years after implantation
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