A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy (NCT00225095) | Clinical Trial Compass
CompletedPhase 1/2
A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
United States60 participantsStarted 2005-09
Plain-language summary
The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy (the surgical removal of all or part of a torn meniscus).
Who can participate
Age range
18 Years – 60 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:
* Age 18 to 60, inclusive
* In need of medial meniscectomy
* Normal axial alignment
* Stable knee- previous ligament reconstruction, if stable
* Removal of at least 50% of the affected portion of the medial meniscus
* Intact articular cartilage in posterior meniscal weight-bearing zone
* Willingness to follow normal post-operative rehabilitation
* Willingness to participate in follow-up for two years from the time of meniscectomy surgery
* Ability to understand and willingness to sign consent form
Exclusion Criteria:
* Pregnant or lactating
* ACL or other support structure damage confirmed at surgery
* Grade III or IV cartilage damage (Cartilage loss greater than 50% thickness in area \>15mm on weight-bearing aspect of femoral condyle or tibial plateau)
* Synvisc, steroid, or corticosteroid injections in preceding 3 months
* Diffuse synovitis at time of arthroscopy
* Inflammatory arthritis
* Oral steroid, methotrexate therapy
* Unable to follow post-operative exercise regimen or return for evaluations
* Active alcohol or substance abuse within 6 months of study entry
* Current and active tobacco product use
* Patient is positive for HIV
* Patient is positive for hepatitis (past history of Hepatitis A is allowed)
* Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
* Indwelling pacemaker
* Cerebral aneurysm clips
* Ear, eye and penile implants with avian components
* Elec…
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.