Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft

Conditions
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Primary Total Hip Arthroplasty

Intervention / Treatment
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* Device: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary total hip endoprosthesis of the side affected (unilateral or bilateral) Patient shall be provided with a HA-coated SL-PLUS™ 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SL-PLUS™ hydroxylapatite coated cement free hip stem<br>Total Hip Arthroplasty using the SL-PLUS™ hydroxylapatite coated cement free hip stem | Device: Total Hip Arthroplasty<br>* Total Hip Arthroplasty using the SL-PLUS™ hydroxylapatite coated cement free hip stem<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 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 | 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 | 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 | up to 10 years after implantation | 
| Survival, Kaplan Meier | Hip implants in situ after 10 years of follow-up | up to 10 years after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic changes | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HA (hydroxylapatite) coated SL-PLUS™ stem