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Randomized controlled trial comparing clinical outcomes of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee to conservative treatment
EU CTIS ID: 2024-514612-27-01
What this study is testing
To compare the level of clinical improvement and quality of life between patients with cartilage defects treated with IMPACT to patients treated with standard care (optional physical therapy and pain medication, no surgical treatment) at 3, 6 and 9 months after randomization.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Symptomatic articular cartilage lesion of the knee (femoral condyles or trochlea)
- Age >18 and <45 years old
- Provides written informed consent, is able to understand the content of the study, understands the requirements for follow-up visits and is willing to provide the required information at follow-up visits and in the questionnaires.
- Modified Outerbridge Grade III or IV isolated cartilage lesion of the knee.
- A post-debridement size of the cartilage lesion > 2cm2 and ≤ 8 cm2
- At least 50% of functional meniscus remaining. Meniscal repair or resection is allowed during the IMPACT surgery provided that the surgeon is able to confirm that at least 50% of functional meniscus remains.
You likely can't join if
- Malalignment of >5 degrees
- (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as determined from appropriate X-ray.
- Concomitant inflammatory disease that affects the joint (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis)
- (History of) Septic arthritis.
- (History of) Total meniscectomy in the target knee joint.
- Any surgery in the knee joint for cartilage treatment 6 months prior to study inclusion.
See the full eligibility criteria
- Symptomatic articular cartilage lesion of the knee (femoral condyles or trochlea)
- Age >18 and <45 years old
- Provides written informed consent, is able to understand the content of the study, understands the requirements for follow-up visits and is willing to provide the required information at follow-up visits and in the questionnaires.
- Modified Outerbridge Grade III or IV isolated cartilage lesion of the knee.
- A post-debridement size of the cartilage lesion > 2cm2 and ≤ 8 cm2
- At least 50% of functional meniscus remaining. Meniscal repair or resection is allowed during the IMPACT surgery provided that the surgeon is able to confirm that at least 50% of functional meniscus remains.
- Stable knee ligaments (i.e. anterior and posterior cruciate ligaments).
- Malalignment of >5 degrees
- (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as determined from appropriate X-ray.
- Concomitant inflammatory disease that affects the joint (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis)
- (History of) Septic arthritis.
- (History of) Total meniscectomy in the target knee joint.
- Any surgery in the knee joint for cartilage treatment 6 months prior to study inclusion.
- Risk groups for MRI scanning due to the magnetic field like patients with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or breast feeding.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.