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Episealer® Knee System IDE Clinical Study | Clinical Trials | Clareo Health

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Episealer® Knee System IDE Clinical Study

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

NCT04000659•Episurf Medical Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be ≥ 30 years and ≤ 70 years.
•2. 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:
•1. ICRS Grade 2, 3 or Grade 4
•2. 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.
•3. Have focal articular defect(s) each with a cartilage lesion area ≥ 1.5 cm2 and ≤ 7.0 cm2.
•1. 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.
•2. 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.
•4. Have screening scores that meet the following criteria:
•1. Visual Analog Scale (VAS) pain score of the index knee of ≥ 40 mm
•2. KOOS Overall Score of ≤ 60
+4 more criteria

Exclusion Criteria

•Subjects who meet any of the following pre-operative screening criteria will be excluded from participation in this study:
•1. Have a Body Mass Index (BMI) greater than 37 kg/m2.
•2. 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.
•3. Have malalignment of \>8 degrees varus or valgus in the index knee based on standard AP x-rays.
•4. Have deficits in flexion or extension of \>10 degrees in the index knee as compared to the contralateral knee.
•5. Have an existing prosthesis in the index knee compartment or opposing joint surface.
•6. Have joint instability in the index knee due to soft tissue or muscular insufficiency.
•7. 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).
•8. Have inadequate bone stock underlying the lesion site, in the opinion of the investigator.
•9. Have any condition, therapy, or medication that may impair bone healing or prevent adequate implant fixation (e.g., osteoporosis).
+26 more criteria

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

Key Dates

Start Date

June 18, 2020

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2028

Last Updated

July 30, 2024

Enrollment

ACTUAL participants

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Interventions

Episealer Knee System

DEVICE

Microfracture

PROCEDURE

Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid

NCT02285725

Unilateral Primary Osteoarthritis of KneeOsteoarthritis Knee+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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