Trials Sponsors Conditions Drugs Pricing

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Sponsors & Collaborators

Permedica spa
Industrylead

Study Sites (1)

Ospedale Centro Ortopedico di Quadrante

Omegna, Verbania, 28887, Italy

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

Study Officials

Marco Spezia, MD
Ospedale Centro Ortopedico di Quadrante
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

186 participants (actual enrollment reported by the registry).

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

Actual (reported)

Total Knee Arthroplasty With Vitamin E Polyethylene

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

VITAMIN E

POLYETHYLENE

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

VITAMIN E

POLYETHYLENE

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations