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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip; Degenerative Osteoarthritis; Rheumatic Arthritis
• Intervention / Treatment: Device: Plasmafit® Vitelene® Vitamin E

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

• Study Contact: Name: Vladimir U Emelianov, MD PhD; Phone Number: +79030633637; Email: emelyanovv@orthoscheb.com

Study Locations

• Russian Federation
  • Chuvashia
    • Cheboksary, Chuvashia, Russian Federation, 429500
      • Federal Center for Traumatology, Orthopedics and Endoprosthetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who need total knee replacmet surgury with a diagnosis

• Pertrochanteric fracture
• Disorder of continuity of tibia bone
• Osteoarthritis of hip
• Polyosteoarthritis
• Acquired deformity of musculoskeletal system
• Ankylosis of joint
• Rheumatoid arthritis

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Plasmafit® Vitelene® Vitamin E ceramic femoral heads; Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and bioceramic femoral heads	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; Other Names: Plasmafit® Acetabular Cup System; BIOLOX delta Ceramic Femoral Head; ISODUR® Metal Femoral Heads
Plasmafit® Vitelene® Vitamin E metal femoral heads; Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and metal femoral heads	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; Other Names: Plasmafit® Acetabular Cup System; BIOLOX delta Ceramic Femoral Head; ISODUR® Metal Femoral Heads
Plasmafit® polyethylene metal femoral heads; Plasmafit® Acetabular Cup System with polyethylene and metal femoral heads

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
• Investigators: Study Chair: Nikolai U Nikolaev, MD PhD, Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Orthopaedic surgery; Hip arthroplasty; Osteoarthritis hip; Vitamin E crosslinked polyethylene; Ceramic femoral heads; Metal femoral heads
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Osteoarthritis; Osteoarthritis, Hip; Rheumatic Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E
• Other Study ID Numbers: 2020-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No