All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects (NCT04785092) | Clinical Trial Compass
CompletedNot Applicable
All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects
Italy20 participantsStarted 2021-03-01
Plain-language summary
The cartilage articular defects of the knee are extremely disabling lesions and represent one of the predisposition causes to the development of articular arthrosis.
When clinical symptoms are present, exist the indication to treat the patient surgically, to this end, several surgical techniques could be performed, as the microfractures, osteochondral transplantation (OCT) or chondrocytes autologous transplantation (ACT).
The aim of this pilot study is to evaluate the clinical performance of a modified version of the ACT technique, the All Autologous Cartilage Repair technique (AACR). A one-step technique in which the healthy cartilage harvested is fragmented directly in situ and then mixed with the autologous platelet concentrate and directly injected in the cartilage defect.. This lead to a less invasive surgery and cost-effective procedure.
The performance will be evaluated through the evaluation of clinical results and complications after surgery other than the evaluation of the quality of the cartilage tissue repaired.
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:
* Singular symptomatic chondral lesion classified as ICRS III or IV at the femoral condyle with less than 3 mm bone damage under the subchondral plate;
* Lesion between 1 and 8 cm2;
* BMI ≤ 34;
* Ability and will to actively participate in a strict rehabilitation protocol and follow-up.
Exclusion Criteria:
* Previous cartilage operation on the injured knee
* Additional grade III or IV lesion on the same knee
* Previous arthroscopic treatments that affect the AACR technique
* Ligamentous/patellofemoral instability/malposition, varus or valgus malposition ≤3° which cannot be treated/corrected simultaneously
* Previous tendon repair, ligament reconstruction or realignment within the last 6 months
* Any known human immunodeficiency virus, hepatitis, syphilis, malignancy or uncontrolled diabetes
* Uncooperative patients who disregard or cannot follow instructions, including those who abuse drugs and/or alcohol
* Participation in a clinical drug or medical device trial that clinically interferes with the present observational study
* Inability to follow procedures (i.e. dementia)
* Inability to give consent
* No understanding of German language
* Pregnant or lactating women
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
Change in knee functionality assessed by KOOS
Timeframe: (before treatment, 6, 12 and 24 months postoperative