All Polyethylene Tibia-VEGA Kiel (NCT02756702) | Clinical Trial Compass
CompletedNot Applicable
All Polyethylene Tibia-VEGA Kiel
Germany70 participantsStarted 2016-03
Plain-language summary
Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation For this PMCF only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b).
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:
* Patients requiring primary TKA because of severe knee joint conditions that cannot be treated through other therapies;
* degenerative osteoarthritis;
* rheumatoid arthritis;
* posttraumatic arthritis;
* symptomatic knee instability;
* knee stiffness or deformation of the knee joint;
* Age ≥ 18 years;
* Patient signed informed consent
Exclusion Criteria:
* Age younger than 18 years
* Any prior joint replacement at the index knee
* Unable or unwilling to return for postoperative follow-up
* Patient did not sign informed consent
* Joint conditions that can be treated by reconstructive surgery (e.g. osteotomy)
* Acute or chronic infections near the joint, or systemic infections
* Secondary diseases that could influence joint implant functionality
* Systemic diseases and metabolic disorders
* Severe osteoporosis or osteomalacia
* Severely damaged bone structures that could prevent stable implantation of implant components
* Bone tumors in the region of implant fixation
* Bone malformations, axial misalignments or other bone conditions that rule out implantation of a prosthetic joint
* Expected overload on the joint implant, especially due to high patient weight or intense physical strain and activity
* Dependency on pharmaceutical drugs, drug abuse, or alcoholism
* Fever, infection or inflammation (systemic or local)
* Pregnancy
* Mental illness
* Severe osteopenia (or any other medical or surgical finding) that would preclude any benefit from the implants…
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.