NCT04358601

Brief Summary

The primary objective is the assessment of prosthetic migration results after two years of the Triathlon PS Knee System with all-polyethylene tibial components compared to the Triathlon PS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.

Trial Health

53
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

April 20, 2020

Last Update Submit

May 6, 2026

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Migration, measured by means of RSA

    Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)

    2 years

Secondary Outcomes (6)

  • Migration, measured by means of RSA

    10 years

  • Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)

    pre-operative, 3 months, 1, 2, 5, 7 and 10 years

  • Investigation of clinical performance and patient outcome with the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire

    pre-operative, 3 months, 1, 2, 5, 7 and 10 years

  • Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire

    pre-operative, 3 months, 1, 2, 5, 7 and 10 years

  • Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire.

    pre-operative, 3 months, 1, 2, 5, 7 and 10 years

  • +1 more secondary outcomes

Study Arms (2)

All-polyethylene tibial components

EXPERIMENTAL

Triathlon PS Knee System with all-polyethylene tibial components

Device: Triathlon PS Knee System with all-polyethylene tibial components

Metal-backed modular components

ACTIVE COMPARATOR

Triathlon PS Knee System with metal-backed modular components

Device: Triathlon PS Knee System with metal-backed modular components

Interventions

Triathlon PS Knee System with metal-backed modular componentsDEVICE

Primary Total Knee Replacement

Also known as: Stryker Orthopaedics
Metal-backed modular components
Triathlon PS Knee System with all-polyethylene tibial componentsDEVICE

Primary Total Knee Replacement

Also known as: Stryker Orthopaedics
All-polyethylene tibial components

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
1\. The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 40. 2. Patient has a flexion contracture of 15° and more. 3. Patient has a varus/valgus contracture of 15° and more. 4. Patients with a pre-operative knee score of \>70. 5. The subject has a history of total or unicompartmental reconstruction of the affected joint. 6. The subject will be operated bilaterally. 7. Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study). 8. Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study). 9. The subject has an active or suspected latent infection in or about the knee joint. 10. Osteomyelitis 11. Sepsis 12. Patient who is expected to need lower limb joint replacement for another joint within one year. 13. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 14. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 15. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 16. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 17. The subject has had a knee fusion to the affected joint. 18. Female patients planning a pregnancy during the course of the study. 19. The patient is unable or unwilling to sign the Informed Consent specific to this study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

November 1, 2014

Primary Completion

September 17, 2017

Study Completion

June 10, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05