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Completed

NCT Number: NCT05291130

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

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

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Key information

Conditions

Osteoarthritis, Hip Arthritis Bacterial Infections Bacterial Infections and Mycoses Connective Tissue Diseases Degenerative Osteoarthritis Gram-Positive Bacterial Infections Infections Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Arthritis Rheumatic Diseases Rheumatic Fever Skin and Connective Tissue Diseases Streptococcal Infections

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal Center for Traumatology, Orthopedics and Endoprosthetics

Cheboksary, Chuvashskaya Respublika, 429500, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

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

Other names: Plasmafit® Acetabular Cup System, BIOLOX delta Ceramic Femoral Head, ISODUR® Metal Femoral Heads

Primary outcomes

  1. Functional assessments of hip joint replacement over time with Harris Hip Score (HHS)

    Time frame: 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.

  2. Functional assessments of knee joint replacement over time with Knee Society Score (KSS)

    Time frame: 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.

  3. Forgotten Joint Score-12 (FJS-12) for knee joint, modified Rankin scale

    Time frame: 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).

  4. Measuring postoperative pain using the visual analog scale for pain (VAS-P)

    Time frame: 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).

  5. The modified Rankin scale (mRS)

    Time frame: 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

Secondary outcomes

  1. The assessment of the assessment of quality of life

    Time frame: 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".

  2. Rentgenological assessments knee and hip replacement over time

    Time frame: 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.

  3. Postoperative complications

    Time frame: 3 year follow-up

    Period of occurrence and type of complications are recorded

  4. Revision surgery

    Time frame: 1 year follow-up

    The incidence of revision, time interval and types of incidence - one or two steps

  5. The quality-adjusted life-year

    Time frame: 3 year follow-up

    Measure of the value of health outcomes with using the Short Form 36 (SF-36) health survey

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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