Comprehensive Segmental Revision System (NCT03270982) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comprehensive Segmental Revision System
Canada, Denmark, United Kingdom105 participantsStarted 2016-04
Plain-language summary
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
Who can participate
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:
* Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis
* Rheumatoid arthritis
* Revision where other devices or treatments have failed
* Correction of functional deformity
* Oncology applications including bone loss due to tumour resection
Exclusion Criteria:
* Sepsis ( active)
* Infection ( active)
* Osteomyelitis (active)
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.
1This trial is studying a 'Comprehensive Segmental Revision System' — can you explain what that implant actually is, and whether it's relevant to my specific diagnosis among the conditions listed, like degenerative disease, trauma, or rheumatoid arthritis?
2Since this trial is listed as 'active, not recruiting,' does that mean I can no longer join it, and if so, are there similar studies or devices my care team is currently using that I could benefit from instead?
3The main thing this trial is measuring is how often the implant needs to be revised or replaced over time — based on what's been observed so far, what does that tell us about the durability and risk of this type of implant compared to other options available to me?
4This trial has no listed phase, which I understand might mean it's a registry or observational study rather than a traditional drug or device trial — can you explain what that means for how safety and effectiveness data is being collected, and how confident you are in the evidence so far?
5Because 'revision surgery' is one of the conditions listed, does this implant system only apply to people who've already had a prior surgery that failed, and does my situation fit that kind of scenario?
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
Implant survivorship assessed according to the implant revisions