TerminatedNot Applicable

Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design

Stopped: Mobile-bearing insert dislocation

Netherlands48 participantsStarted 2008-04

Plain-language summary

The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the MB and FB Triathlon knee.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient (minimum age of 18 years old, no maximum age limit) is diagnosed with osteoarthritis or rheumatoid arthritis and requires primary arthroplasty. * Patient is capable of giving informed consent and expressing a willingness to comply with this study * Patient has no major deformities (i.e. sagittal and coronal deformities are less then 15 degrees) * The ability to perform a lunge and step-up motion without the help of bars or a cane. * No or slight pain during activity according to the Knee Society Pain Score Exclusion Criteria: * The patient is unable or unwilling to sign the Informed Consent specific to this study * The individual has a functional impairment of any other lower extremity joint besides the operated knee * Patient has a flexion contracture of 15° and more * Patient has a varus/valgus contracture of 15° and more * Patients requiring revision arthroplasty * The patient does not understand the Dutch or English language good enough to participate. * The use of walking aids * The inability to walk more than 500 meters

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Migration, measured by means of RSA on the first 20 patients (fluoroscopy subset)

Timeframe: First or second day postoperatively, 6 months, 1 year

Trial details

NCT IDNCT02924961

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-07

View on ClinicalTrials.gov More Complications; Arthroplasty, Mechanical trials