- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04036071
Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft (SL-Plus HA MIA)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Salzburg, Austria, 5020
- Orthopädische Landesklinik Salzburg
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Steyr, Austria, 4400
- Orthopädie LKH Steyr
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Vienna, Austria
- Orthopädisches Krankenhaus Gersthof
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
- Patient shall be provided with a HA coated SLPLUS™ MIA stem
- Patient has no general medical contraindications regarding the surgery
- Signed informed consent form for the participation in the study
- X-ray examinations are possible
- Patient is willing to participate in the post-operative follow-up program
- Age: 18-75 years
Exclusion Criteria:
- Previous failed hip joint surgery (endoprosthesis) of the side affected
- Previous infections in the joint affected; systemic infections
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harris Hip Score
Time Frame: up 10 years after implantation
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The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty
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up 10 years after implantation
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WOMAC Osteoarthritis Index
Time Frame: up 10 years after implantation
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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 |
up 10 years after implantation
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EuroQuol-5D questionnaire
Time Frame: up 10 years after implantation
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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
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up 10 years after implantation
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Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge
Time Frame: up to patient's discharge from the hospital / clinic (from surgery up to 7 days after surgery)
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Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
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up to patient's discharge from the hospital / clinic (from surgery up to 7 days after surgery)
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Postoperative AE up to 10 years after the surgery
Time Frame: up 10 years after implantation
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Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
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up 10 years after implantation
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Survival, Kaplan Meier
Time Frame: up 10 years after implantation
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Hip implants in situ after 10 years of follow-up
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up 10 years after implantation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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up 10 years after implantation
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: K Zweymuller, Orthopädisches Krankenhaus Gersthof
- Principal Investigator: Vinzenz v. Auersperg, Orthopädie LKH Steyr
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- D10080-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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