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Episealer® Knee System IDE Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000659
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
MCRA, LLC
Information provided by (Responsible Party):
Episurf Medical Inc.

Study Description
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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 a focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment.

Condition or disease Intervention/treatment Phase
Degenerative Lesion of Articular Cartilage of Knee Device: Episealer Knee System Procedure: Microfracture Not Applicable

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
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: Single (Participant)
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.
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: Microfracture
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Incidence of Secondary Surgical Intervention [ Time Frame: 24 Months ]
    This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months

  4. Incidence of subsidence or migration at 24 months [ Time Frame: 24 Months ]
    This endpoint will examine the incidence of subsidence/migration at 24 months

  5. Weight bearing status [ Time Frame: 8 weeks ]
    This endpoint will examine the weight bearing status at 8 weeks


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Age between 30 and 70 years
  • Have a single articular cartilage lesion in the femoral condyle or trochlea area
  • Have undergone prior non-surgical management in the index knee

EXCLUSION CRITERIA:

  • Have a BMI greater than 35 kg/m2
  • Have undergone prior surgical treatment for the cartilage defect
  • Have an existing knee prosthesis in the index knee
  • Have a bone disease that impacts bone quality
  • Have rheumatoid arthritis
  • Have a known immunodeficiency
  • Have known allergies to Cobalt-Chrome alloy or Titanium
  • Have any contraindication to MRI
  • Any condition, therapy or medication that would interfere with healing or the evaluation of outcome measures
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Katarina Flodström 1 686 845 9447 Katarina.Flodstrom@episurf.com

Locations
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United States, Indiana
Orthopaedic Research Foundation, Inc. Recruiting
Greenwood, Indiana, United States, 46142
Contact: Vicki Snodgrass Miller    317-884-5230    vsmiller@orthoindy.com   
United States, New York
Plancher Orthopaedics & Sports Medicine Recruiting
New York, New York, United States, 10128
Contact: Stephanie Petterson    203-869-2002    spetterson@ofals.org   
United States, Tennessee
Clinical Research Solutions Recruiting
Jackson, Tennessee, United States, 38305
Contact: Amy Arnold    731-431-5027    aarnold@crssites.com   
Sponsors and Collaborators
Episurf Medical Inc.
MCRA, LLC
Investigators
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Study Director: Katarina Flodström Episurf Medical Inc.
More Information
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Responsible Party: Episurf Medical Inc.
ClinicalTrials.gov Identifier: NCT04000659    
Other Study ID Numbers: IDE 1006
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Episurf Medical Inc.:
Knee
Cartilage