Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee (NCT03321812) | Clinical Trial Compass
UnknownNot Applicable
Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
China60 participantsStarted 2018-09-11
Plain-language summary
The trial evaluates the clinical efficacy and safety of decalcification bone scaffold for cartilage lesions of the knee. Half of participants will receive decalcification bone scaffold combined with microfracture, while the other will only receive microfracture as a control group.
Who can participate
Age range
18 Years – 50 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:
* 18-50 years old, male or female
* Cartilage defect 2-8 cm²
* Subjects have the surgical indication of microfracture and no contradiction
* Subjects participate the clinical trial voluntarily, and sign informed consent
* Subjects could comply with follow-up
Exclusion Criteria:
* Participated in other drug or medical device clinical trials in the last 6 months.
* Can not accept allogeneic decalcified bone due to religion, ethnic and other issues.
* Defect area 2 cm² or 8 cm² or lack of normal cartilage tissue around defect zone.
* Complex multi-ligament injury
* Suffered from systemic immune disease or systemic, locally infected
* Joint fibrosis, joint rigidity, mobility was significantly limited
* Moderate and severe osteoarthritis
* With contraindications to MRI
* Hemophilia
* General condition can not tolerate surgery
* Pregnant or planned pregnant women and lactating women
* With abnormal spirit and selfless ability
* Other circumstances judged by doctors that can not participate in the trial
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.