Total Knee Arthroplasty With Vitamin E Polyethylene

An observational study of Knee Osteoarthritis, run by Permedica spa at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: GKS Prime Flex Mobile knee
Type of treatment: Medical device
How many people: 186 participants
Where: 1 siteItaly
Study dates: 12 Apr 2022to 27 Jun 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ospedale Centro Ortopedico di Quadrante
Omegna, Verbania, 28887

Other trials in Italy

About this study

Conditions: Knee Osteoarthritis
Being tested: GKS Prime Flex Mobile knee
Keywords: total knee arthroplasty, vitamin E, polyethylene, aseptic loosening, osteolysis
Medical subject headings: Osteoarthritis, Knee, Osteolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GKS Prime Flex Mobile kneeDevice
Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis

Study groups in NCT05810285
Study group	Role	What they receive
VITAMIN E		Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing Receives: Device: GKS Prime Flex Mobile knee
POLYETHYLENE		Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing Receives: Device: GKS Prime Flex Mobile knee

What is being measured

The primary outcome is the main question the study is designed to answer.

Implant Survival for Aseptic Loosening
Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point
Measured: 10-year follow-up

Secondary outcomes (5)

Implant Survival for Any Reason
Kaplan-Meier cumulative survival with revision due to any reason as the end-point
Measured: 10-year follow-up
Forgotten Joint Score (FJS-12)
Patient related outcome measurement scored from 0 to 100 (higher scores mean better outcomes)
Measured: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
American Knee Society Score (KSS)
Clinical and Functional scores of the knee. Both scores are scored from 0 to 100 (higher scores mean better outcomes)
Measured: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
Periprosthetic Radiolucent Line
Radiographic sign of bone remodelling around the implant
Measured: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
Periprosthetic Osteolysis
Radiographic sign of focal bone resorption around the implant
Measured: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 202227 Jun 2023

First posted12 Apr 2023
Study start12 Apr 2022
Primary completion27 Jun 2023
Study completion27 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05810285
Sponsor's protocol ID: VITALECOQ2020
Status last verified: Oct 2024
First submitted: 28 Mar 2023
Last updated: 3 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
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Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Total Knee Arthroplasty With Vitamin E Polyethylene
ClinicalTrials.gov ID: NCT05810285
Acronym / sponsor ID: VITALECOQ2020
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty, vitamin E, polyethylene, aseptic loosening, osteolysis
Study type: Observational
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: Permedica spaIndustry (pharma, biotech, devices)
Study start: 12 Apr 2022 (actual)
Primary completion: 27 Jun 2023 (actual)
Study completion: 27 Jun 2023 (actual)
First posted: 12 Apr 2023 (actual)
Results: Posted 6 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
VITAMIN E	–	Device: GKS Prime Flex Mobile kneePatients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing
POLYETHYLENE	–	Device: GKS Prime Flex Mobile kneePatients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GKS Prime Flex Mobile kneeTotal knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis	Device	POLYETHYLENE, VITAMIN E

Primary outcome

Implant Survival for Aseptic Loosening
Time frame: 10-year follow-up
Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point

5 secondary outcomes

Implant Survival for Any Reason
Time frame: 10-year follow-up
Forgotten Joint Score (FJS-12)
Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
American Knee Society Score (KSS)
Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
Periprosthetic Radiolucent Line
Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
Periprosthetic Osteolysis
Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

Results and safety

Results posted to the registry on 6 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VITAMIN E	95	73
POLYETHYLENE	91	54

Primary outcome: Implant Survival for Aseptic Loosening

Time frame: 10-year follow-up. Number (95% Confidence Interval). Unit: percentage of survival implants

Measure	VITAMIN E n = 95	POLYETHYLENE n = 91
Value	95.0 (88.5 to 97.8)	97.8 (91.6 to 99.4)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VITAMIN E	18 of 102 (17.6%)	22 of 102 (21.6%)	4 of 102
POLYETHYLENE	16 of 97 (16.5%)	14 of 97 (14.4%)	21 of 97

Limitations and caveats (from the sponsor): Higher than expected number of knees lost to follow-up. Non homogeneous groups for age, gender, and BMI, which might have biased results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

Recruiting
Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
Osteoarthritis, Knee
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
Knee Osteoarthritis
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marco Spezia, MD principal investigator

Ospedale Centro Ortopedico di Quadrante

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis, run by Permedica spa at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Survival for Aseptic Loosening (time frame: 10-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05810285.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.