Episealer® Knee System IDE Clinical Study
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|ClinicalTrials.gov Identifier: NCT04000659|
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Lesion of Articular Cartilage of Knee||Device: Episealer Knee System Procedure: Microfracture||Not Applicable|
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 a focal femoral chondral or osteochondral lesion 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A total of 180 subjects will be enrolled and randomized using a 2:1 ratio (Episealer: Microfracture). Within each site, subjects will be randomized into one of the two study arms using a blocked randomization scheme with varying block sizes.|
|Masking Description:||In this investigation, neither the investigator nor the subject can be blinded to the treatment group assignment due to the implant's distinctive form that can be detected on radiographs; however, the randomization assignment will not be disclosed to the subject until after surgery is performed.|
|Official Title:||A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Episealer® Knee System Compared to Microfracture for the Treatment of Focal Femoral Knee Chondral or Osteochondral Lesions|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: Episealer Knee System
The experimental arm will comprise of subjects that will be treated with the Episealer Knee System.
Device: Episealer Knee System
The Episealer Knee System is comprised of individualized endoprosthetic resurfacing implants and implantation tools (Episealer Toolkit). The implants are designed to replace the articulating surface which has been damaged due to femoral knee chondral and osteochondral defects.
Placebo Comparator: Microfracture
The control arm will comprise of subjects that will receive a Microfracture surgery.
Microfracture is a minimally invasive surgical technique developed to repair defects in articular cartilage and reduce pain in the knee joint. Microfracture techniques are described in the orthopedic literature and are performed arthroscopically.
- Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores [ Time Frame: 24 Months ]This endpoint will examine the change in KOOS subscores at 24 months
- Change in Visual Analog Scale (VAS) Pain Scores [ Time Frame: 24 Months ]This endpoint will examine the change in VAS Pain scores at 24 months
- Incidence of Secondary Surgical Intervention [ Time Frame: 24 Months ]This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months
- Incidence of subsidence or migration at 24 months [ Time Frame: 24 Months ]This endpoint will examine the incidence of subsidence/migration at 24 months
- Weight bearing status [ Time Frame: 8 weeks ]This endpoint will examine the weight bearing status at 8 weeks
- Change in the KOOS Subscores at all follow-up time points [ Time Frame: 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
- Change in VAS Pain score at all follow-up time points [ Time Frame: 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
- Change in 12-Item Short Form Survey (SF-12) score at all follow-up time points [ Time Frame: 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
- Incidence of radiographic findings at all follow-up time points [ Time Frame: 8 weeks, 12-months, and 24-months ]This endpoint will examine the incidence of radiographic findings at all follow-up time points
- Incidence of adverse events and device deficiencies at all follow-up time points [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000659
|Contact: Katarina Flodström||1 686 845 9447||Katarina.Flodstrom@episurf.com|
|United States, Indiana|
|Orthopaedic Research Foundation, Inc.||Recruiting|
|Greenwood, Indiana, United States, 46142|
|Contact: Vicki Snodgrass Miller 317-884-5230 firstname.lastname@example.org|
|United States, New York|
|Plancher Orthopaedics & Sports Medicine||Recruiting|
|New York, New York, United States, 10128|
|Contact: Stephanie Petterson 203-869-2002 email@example.com|
|United States, Tennessee|
|Clinical Research Solutions||Recruiting|
|Jackson, Tennessee, United States, 38305|
|Contact: Amy Arnold 731-431-5027 firstname.lastname@example.org|
|Study Director:||Katarina Flodström||Episurf Medical Inc.|