Episealer® Knee System IDE Clinical Study
- Conditions
- Degenerative Lesion of Articular Cartilage of Knee
- Registration Number
- NCT04000659
- Lead Sponsor
- Episurf Medical Inc.
- Brief 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.
- Detailed Description
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Episealer Knee System (Episealer Trochlea Solo, Episealer Femoral Twin, and Episealer Condyle Solo) compared to microfracture (with or without debridement) in a group of subjects that require repair of up to 2 focal femoral chondral or osteochondral lesions in the knee.
Clinical success will be analyzed via subject reported outcomes to measure function and pain improvements as compared to baseline, incidence of secondary surgical interventions for the treated knee, absence of subsidence or migration through radiographic assessment, and assessment of weight-bearing status.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of subsidence or migration at 24 months 24 Months This endpoint will examine the incidence of subsidence/migration at 24 months
Incidence of Secondary Surgical Intervention 24 Months This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months
Change in Visual Analog Scale (VAS) Pain Scores 24 Months This endpoint will examine the change in VAS Pain scores at 24 months
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores 24 Months This endpoint will examine the change in KOOS subscores at 24 months
Weight bearing status 8 weeks This endpoint will examine the weight bearing status at 8 weeks
- Secondary Outcome Measures
Name Time Method Change in 12-Item Short Form Survey (SF-12) score at all follow-up time points 3-weeks, 8-weeks, 6-months, 12-months, and 24-months This endpoint will examine the change in SF-12 scores at all follow-up time points
Change in VAS Pain score at all follow-up time points 3-weeks, 8-weeks, 6-months, 12-months, and 24-months This endpoint will examine the change in VAS Pain scores at all follow-up time points
Incidence of adverse events and device deficiencies at all follow-up time points 3-weeks, 8-weeks, 6-months, 12-months and 24-months This endpoint will examine the safety via the incidence of adverse events and device deficiencies at all follow-up time points
Incidence of radiographic findings at all follow-up time points 8 weeks, 12-months, and 24-months This endpoint will examine the incidence of radiographic findings at all follow-up time points
Change in the KOOS Subscores at all follow-up time points 3-weeks, 8-weeks, 6-months, 12-months, and 24-months This endpoint will examine the change in KOOS subscores at all follow-up time points
Trial Locations
- Locations (13)
Physicians Research Group
🇺🇸Tempe, Arizona, United States
Horizon Clinical Research
🇺🇸La Mesa, California, United States
Ochsner Sports Medicine Institute
🇺🇸New Orleans, Louisiana, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Plancher Orthopaedics & Sports Medicine
🇺🇸New York, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Helios Clinical Research
🇺🇸Jackson, Tennessee, United States
North Texas Medical Research Institute
🇺🇸Dallas, Texas, United States
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Universitatsmedizin Berlin Charite
🇩🇪Berlin, Germany
Scroll for more (3 remaining)Physicians Research Group🇺🇸Tempe, Arizona, United States