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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291130
• Other study ID #: 2020-3
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2022
• Source: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All patients who needs total knee replacement surgery

• Informed consent from the patients.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Degenerative Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Rheumatic Arthritis
• Rheumatic Fever

Intervention

Device:
• Plasmafit® 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

Locations

Country	Name	City	State
Russian Federation	Federal Center for Traumatology, Orthopedics and Endoprosthetics	Cheboksary	Chuvashia

Sponsors (1)

Lead Sponsor	Collaborator
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Postoperative complications	Period of occurrence and type of complications are recorded	3 year follow-up
Secondary	Revision surgery	The incidence of revision, time interval and types of incidence - one or two steps	1 year follow-up
Secondary	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