Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee. (NCT00793104) | Clinical Trial Compass
TerminatedPhase 3
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Stopped: Slow enrolment \& potential regulatory changes for allograft in cartilage repair
United States10 participantsStarted 2008-11
Plain-language summary
Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
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:
* 18 years of age or older
* Skeletally mature
* Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
* Functional meniscal tissue (defined as 5 mm or more width)
* A score of = or greater than 4 on the VAS questionnaire
Exclusion Criteria:
* Associated tibial or patellar articular cartilage defect greater than 2 ICRS
* Osteoarthritis of either knee
* Mechanical axis malalignment of greater than 5 degrees
* Patellofemoral incongruity of Merchant view
* One or more multiple defects greater than 2.5 cm
* Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
* Ligament treatments in the affected knee within one yer prior to current study
* Previous surgical meniscus treatments in the affected knee in the last 6 months
* Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
* Use of any investigational therapy with in 30 days prior to the first visit
* Corticosteroid or viscosupplementation within the past 3 months
* A score of 3 or less on the VAS Questionnaire
* Active gout or pseudogout or systemic inflammatory condition
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
1
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months