AESCULAP® Plasmafit® Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene

Study Overview
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Brief Summary
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Objectives of this study is evaluate effectivness of AESCULAP® Plasmafit® Plasmafit Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene compare to the sane sistem without Vitamin E, and ceramic or metal femoral heads

Detailed Description
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Osteoarthritis is one most common disease in aged population, that most advanced stage needs surgical treatment. Surgical treatment usually include installation of implants. Every year new types of implants were fabricated from the new material. The effectiveness of this new devices need carefully independent assess in clinic.

Official Title
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Evaluation Effectiveness of the Aesculap® Plasmafit Cementless Acetabular System in Combination With Vitelene® Polyethylene and Vitamin E Insert for Hip Arthroplasty

Conditions
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Rheumatic Arthritis, Osteoarthritis, Hip, Degenerative Osteoarthritis

Intervention / Treatment
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* Device: Plasmafit® Vitelene® Vitamin E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who needs total knee replacement surgery Informed consent from the patients. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Plasmafit® Vitelene® Vitamin E ceramic femoral heads<br>Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and bioceramic femoral heads | Device: Plasmafit® Vitelene® Vitamin E<br>* Plasmafit® Acetabular Cup System with an insert Aesculap ® Vitelene ® Vitamin E Stabilized Highly Crosslinked Polyethylene and BIOLOX delta Ceramic Femoral Head or ISODUR® Metal Femoral Heads<br>* Other names: ISODUR® Metal Femoral Heads;|
| Plasmafit® Vitelene® Vitamin E metal femoral heads<br>Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and metal femoral heads | Device: Plasmafit® Vitelene® Vitamin E<br>* Plasmafit® Acetabular Cup System with an insert Aesculap ® Vitelene ® Vitamin E Stabilized Highly Crosslinked Polyethylene and BIOLOX delta Ceramic Femoral Head or ISODUR® Metal Femoral Heads<br>* Other names: ISODUR® Metal Femoral Heads;|
| Plasmafit® polyethylene metal femoral heads<br>Plasmafit® Acetabular Cup System with polyethylene and metal femoral heads | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional assessments of hip joint replacement over time with Harris Hip Score (HHS) | The HHS is a measure of dysfunction of the hip joint. Consist of 10 items in 3 sections. Score <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 3 year follow-up | 
| Functional assessments of knee joint replacement over time with Knee Society Score (KSS) | The KSS is a measure of dysfunction of the knee joint. The KSS has a two sections: Knee Score section (7 items) and a Functional Score section (3 items). Results can be interpreted with the following: 80-100 = excellent; score 70-79 = good; score 60-69 = fair; score <60 = poor. | 3 year follow-up | 
| Forgotten Joint Score-12 (FJS-12) for knee joint, modified Rankin scale | FJS-12 shows how much did the patient forget their artificial joint. Consists of 12 items, each item is answered within a 5-point Likert scale, as follows: 0: never (0 p); almost never (1 p); seldom (2 p); sometimes (3 p); and mostly (4 p). The initial raw data were converted to a scale ranging from 0 to 100 (worst to best). | 3 year follow-up | 
| Measuring postoperative pain using the visual analog scale for pain (VAS-P) | To measure pain intensity after surgery the patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain). | 3 year follow-up | 
| The modified Rankin scale (mRS) | mRS was used scale for measuring the degree of disability or dependence in the daily activities after joint replacement, with the following response options: 0: No symptoms at all; 1: No significant disability despite symptoms; able to carry out all usual duties and activities; 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate disability; requiring some help, but able to walk without assistance; 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6: Dead | 3 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The assessment of the assessment of quality of life | The assessment of quality of life using EQ-5D measure: mobility, self-care, usual activities, pain/discomfort and anxiety/depression based on a three-level version included no problems, slight problems, moderate problems, severe problems, and unable to do/extreme. | 3 year follow-up | 
| Rentgenological assessments knee and hip replacement over time | Rentgenological results based on standing anteroposterior pelvic radiograph with assesment version, acetabular interclination, depth, height, stability of endoprosthesis components, signs of wear on the insert, presence of osteolysis zones. Installing additional locking screws, acetabular cup anteversion and inclination, limb length discrepancy after surgery. | 3 year follow-up | 
| Postoperative complications | Period of occurrence and type of complications are recorded | 3 year follow-up | 
| Revision surgery | The incidence of revision, time interval and types of incidence - one or two steps | 1 year follow-up | 
| The quality-adjusted life-year | Measure of the value of health outcomes with using the Short Form 36 (SF-36) health survey | 3 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis hip, Orthopaedic surgery, Vitamin E crosslinked polyethylene, Hip arthroplasty, Ceramic femoral heads, Metal femoral heads