NCT05810285

Brief Summary

The aim of this observational study is to investigate if there is any difference in survival rate, clinical and radiological results after total knee replacement with vitamin E-blended polyethylene in comparison to conventional polyethylene at minimum 7-year follow-up

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 6, 2024

Completed
Last Updated

January 3, 2025

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

March 28, 2023

Results QC Date

July 25, 2024

Last Update Submit

December 16, 2024

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplastyvitamin Epolyethyleneaseptic looseningosteolysis

Outcome Measures

Primary Outcomes (1)

  • Implant Survival for Aseptic Loosening

    Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point

    10-year follow-up

Secondary Outcomes (5)

  • Implant Survival for Any Reason

    10-year follow-up

  • Forgotten Joint Score (FJS-12)

    At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

  • American Knee Society Score (KSS)

    At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

  • Periprosthetic Radiolucent Line

    At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

  • Periprosthetic Osteolysis

    At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

Study Arms (2)

VITAMIN E

Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing

Device: GKS Prime Flex Mobile knee

POLYETHYLENE

Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing

Device: GKS Prime Flex Mobile knee

Interventions

GKS Prime Flex Mobile kneeDEVICE

Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis

POLYETHYLENEVITAMIN E

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing

You may qualify if:

  • Patient who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing.
  • Minimum 7-year follow-up;
  • Age ≥ 18 and \< 85 years;
  • Patient who signed informed consent.

You may not qualify if:

  • Patient who received primary cemented total knee arthroplasty with a different knee prosthetic design;
  • Patient already enrolled in other clinical studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Centro Ortopedico di Quadrante

Omegna, Verbania, 28887, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteolysis

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone ResorptionBone Diseases

Limitations and Caveats

Higher than expected number of knees lost to follow-up. Non homogeneous groups for age, gender, and BMI, which might have biased results.

Results Point of Contact

Title
Lorenzo Banci, study coordinator - clinical affairs
Organization
Permedicaspa
lorenzo.banci@permedica.it
0399514811

Study Officials

  • Marco Spezia, MD

    Ospedale Centro Ortopedico di Quadrante

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 12, 2023

Study Start

April 12, 2022

Primary Completion

June 27, 2023

Study Completion

June 27, 2023

Last Updated

January 3, 2025

Results First Posted

December 6, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)