Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty

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

ACTIVE_NOT_RECRUITING

Total Enrollment

605 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2034-10-31

Brief Summary

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Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty

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Detailed Description

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Conditions

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Osteoarthritis, Knee Arthritis, Rheumatoid Intra-Articular Fractures Joint Instability Genu Valgum or Varum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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With Vitamin E

UHMWPE with Vitamin E

Intervention Type DEVICE

e.motion Pro (PS and UC) with MXE gliding surface

Without Vitamin E

UHMWPE without Vitamin E

Intervention Type DEVICE

e.motion Pro (PS and UC) with β-PE gliding surface

Interventions

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UHMWPE with Vitamin E

e.motion Pro (PS and UC) with MXE gliding surface

Intervention Type DEVICE

UHMWPE without Vitamin E

e.motion Pro (PS and UC) with β-PE gliding surface

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Indication for a total knee replacement with a mobile-bearing UC or PS inlay
* Written informed consent for participating at the clinical study
* Willingness and mental ability to participate at the long-term follow-up examinations