Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate t… (NCT04475341) | Clinical Trial Compass
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Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate the Key to Success?
96 participantsStarted 2020-09-01
Plain-language summary
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.
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:
* Patients with a symptomatic OCL of the talus who are scheduled for arthroscopic debridement and microfracture
* OCL depth and/or diameter ≤ 15 mm on computed tomography medial-lateral and/or anterior-posterior
* Age 18 years or older
* Intact remaining articular cartilage of the joint Kellgren-Lawrence stage 0-1
Exclusion Criteria:
* Concomitant OCL of the tibia
* Ankle osteoarthritis grade 2 or 3 van Dijk et al. \[53\]
* Ankle fracture \< 6 months before scheduled arthroscopy
* Inflammatory arthropathy (e.g Rheumatoid arthritis)
* History of (or current) hemopoeitic disease or immunotherapy
* Acute or chronic instability of the ankle
* Use of prescribed orthopaedic shoewear
* Other concomitant painful or disabling disease of the lower limb
* Pregnancy
* Implanted pacemaker
* Participation in previous trials \< 1 year, in which the subject has been exposed to radiation (radiographs or CT)
* Patients who are unable to fill out questionnaires and cannot have them filled out
* No informed consent
* HIV positive or hepatitis B or C infection (based on the anamnesis of the patient)
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
Numeric Rating Scale of Pain During Weightbearing
Timeframe: 2 years post-operatively
Trial details
NCT IDNCT04475341
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)