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

NCT05291130 | Completed DMC FDA Device

• 1 other identifier: 2020-3
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis, Hip; Rheumatic Arthritis; Degenerative Osteoarthritis

Keywords

Osteoarthritis hip; Orthopaedic surgery; Vitamin E crosslinked polyethylene; Hip arthroplasty; Ceramic femoral heads; Metal femoral heads

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• The assessment of the assessment of quality of life

  3 year follow-up

• Rentgenological assessments knee and hip replacement over time

  3 year follow-up

• Postoperative complications

  3 year follow-up

• Revision surgery

  1 year follow-up

• The quality-adjusted life-year

  3 year follow-up

Study Arms (3)

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® 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® polyethylene metal femoral heads

Plasmafit® Acetabular Cup System with polyethylene and metal femoral heads

Interventions

Plasmafit® Vitelene® Vitamin E DEVICE

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

Also known as: Plasmafit® Acetabular Cup System, BIOLOX delta Ceramic Femoral Head, ISODUR® Metal Femoral Heads

Plasmafit® Vitelene® Vitamin E ceramic femoral heads; Plasmafit® Vitelene® Vitamin E metal femoral heads

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty: lead

Study Sites (1)

Federal Center for Traumatology, Orthopedics and Endoprosthetics

Cheboksary, Chuvashskaya Respublika, 429500, Russia

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Rheumatic Fever; Joint Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nikolai U Nikolaev, MD PhD

  Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: March 22, 2022
• Study Start: August 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 6, 2023

Record last verified: 2022-03

Locations

RU (1)