Status:
UNKNOWN
Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate the Key to Success?
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Osteochondral Lesion of Talus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 2 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04475341
Start Date
September 1 2020
End Date
September 2 2024
Last Update
July 17 2020
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