Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining -… (NCT02525601) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented
Sweden60 participantsStarted 2009-03
Plain-language summary
The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.
Who can participate
Age range
18 Years – 85 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
. Patients suffering exclusively from osteo arthritis, Stage II-V \[Ahlbäck Trauma Score, 1968 391\] will be operated.
. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.
. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.
Exclusion criteria
. Previous major knee surgery
. Other significant disabling problems from the muscular-skeletal system than in the knees
. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).
. Patients with active or suspected infection.
. Patients with malignancy - active malignancy.
. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
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
1
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
Timeframe: 10 years follow-up; UPDATE: time frame extended up to 15 years outcomes
. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.