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

NCT ID: NCT05291130

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-08-01

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Hip Rheumatic Arthritis Degenerative Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Plasmafit® Vitelene® Vitamin E

Intervention Type 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

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

Plasmafit® Vitelene® Vitamin E

Intervention Type 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

Plasmafit® polyethylene metal femoral heads

Plasmafit® Acetabular Cup System with polyethylene and metal femoral heads

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Plasmafit® Acetabular Cup System BIOLOX delta Ceramic Femoral Head ISODUR® Metal Femoral Heads

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikolai U Nikolaev, MD PhD

Role: STUDY_CHAIR

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

Locations

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Federal Center for Traumatology, Orthopedics and Endoprosthetics

Cheboksary, Chuvashskaya Respublika, Russia

Site Status

Countries

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Russia

Other Identifiers

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2020-3

Identifier Type: -

Identifier Source: org_study_id

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