Clinical trial NCT04618016: Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Knee
Arthritis, Rheumatoid
Intra-Articular Fractures
Joint Instability
Genu Valgum or Varum
Keywords: Total Knee Arthroplasty
Range of motion
Treatment outcome
Ultrahighmolecular Weight Polyethylene with Vitamin E
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Raylytic GmbH
name: B. Braun Medical France
First posted: 2020-11-05
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: multicentric

Brief summary: 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


Eligibility criteria: 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

Exclusion Criteria:

* Patient age \< 18 and \> 80 years
* Pregnancy
* High risk patients (ASA class \>3)

Primary outcomes:
measure: Clinical Outcome measured with the KSS [performance]
timeFrame: 10 years postoperatively
Secondary outcomes:
measure: Survival rate
timeFrame: until the last follow-up at 10 years postoperatively
measure: Progress of Clinical Outcome [Oxford Score] compared to baseline
timeFrame: Preoperatively, 3 months, 12 months, 3 years, 5 years, 7 years, 10 years
measure: Quality of Life [EQ-5D-5L]
timeFrame: Preoperatively, 3 months, 12 months, 5 years, 10 years
measure: Comparison of Radiographic evaluation over time
timeFrame: baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
measure: Comparison of Radiographic alignment over time
timeFrame: baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
measure: Oxidation profile and wear analysis of available retrievals
timeFrame: During the course of the study up to 10 years postoperatively
measure: Further analysis of patients having a revision of the primary implant
timeFrame: During the course of the study up to 10 years postoperatively
measure: (Serious) Adverse Events
timeFrame: During the course of the study up to 10 years postoperatively
Other outcomes:
Locations:
city: Echirolles
country: France
facility: Hôpital Sud - CHU de Grenoble
state: Isere
city: Amiens cedex
country: France
facility: CHU Amiens-Picardie
city: Bünde
country: Germany
facility: Lukas Krankenhaus
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Brüderhaus Koblenz
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Park-Klinik Weißensee
city: Eisenberg
country: Germany
facility: Waldkliniken Eisenberg
city: Reinbek
country: Germany
facility: Krankenhaus Reinbek, St. Adolf Stift
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock, Klinik für Orthopädie
Study officials:
affiliation: Orthopädische Uniklinik Rostock, Direktor
name: Wolfram Mittelmeier, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: