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.
Study Type
OBSERVATIONAL
Enrollment
100
Total Hip Arthroplasty using the SL-PLUS™ hydroxylapatite coated cement free hip stem
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. 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.
Time frame: up to 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: 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 I off toilet, heavy domestic duties, light domestic duties
Time frame: up to 10 yeares 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 to 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: 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 to 10 years after implantation
Survival, Kaplan Meier
Hip implants in situ after 10 years of follow-up
Time frame: up to 10 years after implantation
Radiographic changes
Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.
Time frame: up to 10 years after implantation
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