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

Completed

• Conditions: Rheumatic Arthritis; Degenerative Osteoarthritis; Osteoarthritis, Hip
• Interventions: Device: Plasmafit® Vitelene® Vitamin E

• Registration Number: NCT05291130
• Lead Sponsor: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

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.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2021-12-15
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• All patients who needs total knee replacement surgery
• Informed consent from the patients.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Plasmafit® Vitelene® Vitamin E ceramic femoral heads	Plasmafit® Vitelene® Vitamin E	Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and bioceramic femoral heads
Plasmafit® Vitelene® Vitamin E metal femoral heads	Plasmafit® Vitelene® Vitamin E	Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and metal femoral heads

Primary Outcome Measures

Name	Time	Method
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.
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).
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
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).

Secondary Outcome Measures

Name	Time	Method
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.
Revision surgery	1 year follow-up	The incidence of revision, time interval and types of incidence - one or two steps
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".
Postoperative complications	3 year follow-up	Period of occurrence and type of complications are recorded
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

Trial Locations

Locations (1)

Federal Center for Traumatology, Orthopedics and Endoprosthetics; 🇷🇺 Cheboksary, Chuvashia, Russian Federation