Episealer® Knee System IDE Clinical Study (NCT04000659) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Episealer® Knee System IDE Clinical Study
United States, Canada, Germany13 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 range
30 Years – 70 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
. 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.
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
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores
. 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.
. 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.