Episealer® Knee System IDE Clinical Study (NCT04000659) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Episealer® Knee System IDE Clinical Study
United States13 participantsStarted 2020-06-18
Plain-language summary
The study is a randomized, prospective, multicenter, controlled clinical trial of the Episealer Knee System. The Episealer Knee System is intended for subjects with up to two focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment.
Who can participate
Age range30 Years – 70 Years
SexALL
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Inclusion criteria
✓. Be ≥ 30 years and ≤ 70 years.
✓. Have up to 2 symptomatic femoral chondral or osteochondral defects in the index knee on the medial or lateral femoral condyles or the knee trochlea area, which are:
✓. ICRS Grade 2, 3 or Grade 4
✓. Each suitable for treatment with 1 Episealer device NOTE: Additional femoral cartilage lesions which, in the opinion of the investigator, are asymptomatic and free from underlying bone lesions (e.g., bone edema) will not be treated.
✓. Have focal articular defect(s) each with a cartilage lesion area ≥ 1.5 cm2 and ≤ 7.0 cm2.
✓. Subjects with up to two defects ≥ 1.5 cm2 and ≤ 4.0 cm2, that are surrounded by adequate circumferential cartilage as determined by the investigator, will be randomized.
✓. Subjects with at least one defect \> 4.0 cm2 and ≤ 7.0 cm2, with adequate bony support as determined by the investigator, will not be randomized, and will receive the Episealer device.
✓. Have screening scores that meet the following criteria:
Exclusion criteria
✕. Have a Body Mass Index (BMI) greater than 37 kg/m2.
✕. Have an ICRS Grade 3 or 4 tibial lesion of any size, or an ICRS Grade 4 patella lesion/fissure ≥ 2.0 mm in width in the index knee.
✕. Have malalignment of \>8 degrees varus or valgus in the index knee based on standard AP x-rays.
What they're measuring
1
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores
✕. Have deficits in flexion or extension of \>10 degrees in the index knee as compared to the contralateral knee.
✕. Have an existing prosthesis in the index knee compartment or opposing joint surface.
✕. Have joint instability in the index knee due to soft tissue or muscular insufficiency.
✕. Have a vascular insufficiency at the lesion site that will impair successful microfracture (e.g., avascular necrosis/osteonecrosis, osteochondritis dissecans). (NOTE: This exclusion will not apply to patients with lesions between 4.0-7.0 cm2 who will not undergo randomization and will be treated in the Episealer-only arm).
✕. Have inadequate bone stock underlying the lesion site, in the opinion of the investigator.