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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.
Full 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.
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Inclusion and exclusion criteria
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:
Have focal articular defect(s) each with a cartilage lesion area ≥ 1.5 cm2 and ≤ 7.0 cm2.
Have screening scores that meet the following criteria:
Have experienced knee pain symptoms and undergone prior non-surgical management (e.g., physical therapy, bracing, HA injections) for at least 4 weeks prior to being considered for the study.
Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
Be willing and able to comply with all study procedures including all pre-operative, post-operative, and rehabilitation requirements.
If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant in the next 24 months.
EXCLUSION CRITERIA
Pre-Operative Exclusion Criteria
Subjects who meet any of the following pre-operative screening criteria will be excluded from participation in this study:
Intra-operative Exclusion Criteria
Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:
Have any meniscus tears or defects that require resection of more than 1/3 of the meniscus in the compartment to be treated (i.e., medial meniscus when medial femoral compartment is being treated; lateral meniscus when lateral femoral compartment is being treated).
Have chondrosis of the non-operative patellofemoral compartment, contralateral compartment or medial or lateral proximal tibia greater than Outerbridge Grade 2.
Have an index lesion on the articular surface that lacks adequate circumferential cartilage as determined by the investigator (NOTE: This exclusion applies only to patients randomized to the microfracture arm.)
Applicable to Investigational Group Only
Have a defect undergoing treatment that cannot be adequately covered by the Episealer device based on intra-operative measurements.
Have bone quality which, in the judgment of the surgeon, would prevent satisfactory fixation of the investigational device.
Primary purpose
Allocation
Interventional model
Masking
13 participants in 2 patient groups, including a placebo group
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Central trial contact
Katarina Flodström
Data sourced from clinicaltrials.gov
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