CompletedNot Applicable

COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients

Spain100 participantsStarted 2022-03-16

Plain-language summary

The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations or treatment measures. The treatment will be carried out exclusively according to medical standards. The study therefore only serves the purpose of observing this standard-compliant treatment and specifically documenting it scientifically.

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 underwent navigated revision surgery using the Columbus® Revision knee prosthesis (case group) * Patient underwent conventional manual revision surgery using another implant system (control group) * Written informed consent Exclusion Criteria: * Pregnancy * Patient Age at time of revision surgery \< 18 years * Allergy to any prosthesis component

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

Compare the final joint line height between groups after the surgical restoration of native joint line height of revision implants

Timeframe: Comparison of final joint line height before the surgery with height at the 3 months follow-up

Trial details

NCT IDNCT05113303

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-16

View on ClinicalTrials.gov More Knee Osteoarthritis trials