The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.
This is a prospective, open-label, single-arm pilot study designed to investigate the safety and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects. All patients who meet eligibility criteria and who consent to participate will undergo the implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells via arthrotomy. Patients will be followed-up for 2 years at regular intervals. Evaluations will include adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic and histologic evaluations and MRIs (including dGEMRIC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
INSTRUCT PolyActive scaffold implantation
University Hospital Gent
Ghent, Belgium
University Hospital nber 2 Dr. Jana Biziela
Bydgoszcz, Poland
NZOZ "Szpital AVIMED" sp. z o.o.
Katowice, Poland
NZOZ Endomedical
Poznan, Poland
Incidence of related adverse events
Time frame: Over 24 months
Lesion filling
Time frame: 3 months
Incidence of non-related adverse events
Time frame: 24 months
KOOS, IKDC and pain VAS scores
Time frame: At all timepoints over 24 months
Histopathology assessments
Time frame: 6 or 12 months
MRI evaluation of structural repair
Time frame: Discharge, 3, 6, 12 and 24 months
dGEMRIC assessment of structural repair
Time frame: 6, 12 and 24 months
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Centrum Medycyny Sportowej (Sports Medicine Center CMS)
Warsaw, Poland
Royal Orthopaedic Hospital
Birmingham, United Kingdom