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

NCT04618016 | Active Not Recruiting

• 1 other identifier: AAG-O-H-1906
• Study Type: observational
• Target: 605
• Locations: 2 countries
• Sites: 8

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

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

Outcome Measures

Primary Outcomes (1)

• Clinical Outcome measured with the KSS [performance]

  The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.

  10 years postoperatively

Secondary Outcomes (8)

• Survival rate

  until the last follow-up at 10 years postoperatively

• Progress of Clinical Outcome [Oxford Score] compared to baseline

  Preoperatively, 3 months, 12 months, 3 years, 5 years, 7 years, 10 years

• Quality of Life [EQ-5D-5L]

  Preoperatively, 3 months, 12 months, 5 years, 10 years

• Comparison of Radiographic evaluation over time

  baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years

• Comparison of Radiographic alignment over time

  baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years

Study Arms (2)

With Vitamin E

Device: UHMWPE with Vitamin E

Without Vitamin E

Device: UHMWPE without Vitamin E

Interventions

UHMWPE without Vitamin E DEVICE

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

Without Vitamin E

UHMWPE with Vitamin E DEVICE

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

With Vitamin E

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

multicentric

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Raylytic GmbH: collaborator
• Aesculap AG: lead
• B. Braun Medical France: collaborator

Study Sites (8)

Hôpital Sud - CHU de Grenoble

Échirolles, Isere, 38130, France

Location

CHU Amiens-Picardie

Amiens, 80054, France

Location

Lukas Krankenhaus

Bünde, North Rhine-Westphalia, 32257, Germany

Location

Brüderhaus Koblenz

Koblenz, Rhineland-Palatinate, 56073, Germany

Location

Park-Klinik Weißensee

Berlin, 13086, Germany

Location

Waldkliniken Eisenberg

Eisenberg, 07607, Germany

Location

Krankenhaus Reinbek, St. Adolf Stift

Reinbek, 21465, Germany

Location

Universitätsklinikum Rostock, Klinik für Orthopädie

Rostock, 18057, Germany

Location

Related Publications (1)

• Maier K, Selig M, Haddouche A, Haunschild M, Hauschild O, Khalili I, Kirschberg J, Lutter C, Menges M, Mertl P, Niemeier A, Rubens-Duval B, Mittelmeier W. Vitamin E-enriched medium cross-linked polyethylene in total knee arthroplasty (VIKEP): clinical outcome, oxidation profile, and wear analysis in comparison to standard polyethylene-study protocol for a randomized controlled trial. Trials. 2024 Jan 5;25(1):27. doi: 10.1186/s13063-023-07811-1.

  PMID: 38183062 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Fractures, Bone; Wounds and Injuries; Bone Diseases

Study Officials

• Wolfram Mittelmeier, Prof. Dr.

  Orthopädische Uniklinik Rostock, Direktor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 5, 2020
• Study Start: March 8, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): October 1, 2034
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (2); DE (6)