Degenerative Osteoarthritis, Osteoarthritis, Hip, Rheumatic Arthritis
Conditions
Keywords
Osteoarthritis hip, Orthopaedic surgery, Vitamin E crosslinked polyethylene, Hip arthroplasty, Ceramic femoral heads, Metal femoral heads
Brief summary
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
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.
Interventions
DEVICEPlasmafit® Vitelene® Vitamin E
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
Sponsors
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* All patients who needs total knee replacement surgery * Informed consent from the patients.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The modified Rankin scale (mRS) | 3 year follow-up | 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 |
| Functional assessments of hip joint replacement over time with Harris Hip Score (HHS) | 3 year follow-up | 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. |
| Functional assessments of knee joint replacement over time with Knee Society Score (KSS) | 3 year follow-up | 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. |
| Measuring postoperative pain using the visual analog scale for pain (VAS-P) | 3 year follow-up | 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). |
| Forgotten Joint Score-12 (FJS-12) for knee joint, modified Rankin scale | 3 year follow-up | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The assessment of the assessment of quality of life | 3 year follow-up | 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. |
| Rentgenological assessments knee and hip replacement over time | 3 year follow-up | 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. |
| Postoperative complications | 3 year follow-up | Period of occurrence and type of complications are recorded |
| Revision surgery | 1 year follow-up | The incidence of revision, time interval and types of incidence - one or two steps |
| The quality-adjusted life-year | 3 year follow-up | Measure of the value of health outcomes with using the Short Form 36 (SF-36) health survey |
Countries
Russia
Outcome results
None listed