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

NCT05291130 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2023-07-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Nikolai U Nikolaev, MD PhD · Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-08-01
Completion
2022-08-01
FDA Device
Yes

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291130 on ClinicalTrials.gov