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Orthopedic Implant
Episealer Knee System vs Microfracture Surgery for Osteoarthritis
N/A
Recruiting
Research Sponsored by Episurf Medical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have screening scores that meet the following criteria: Visual Analog Scale (VAS) pain score of the index knee of ≥ 40 mm KOOS Overall Score of ≤ 60
Have focal articular defect(s) each with a cartilage lesion area ≥ 1.5 cm2 and ≤ 7.0 cm2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-weeks, 8-weeks, 6-months, 12-months and 24-months
Awards & highlights
Study Summary
This trial will compare the Episealer Knee System to microfracture surgery, a common treatment for this condition.
Who is the study for?
This trial is for adults aged 30-70 with knee pain from osteoarthritis, who have one or two specific types of knee damage that can be treated surgically. Participants should not be pregnant, planning pregnancy within 24 months, or have a BMI over 37. They must not have certain other knee conditions, previous treatments within six months (except debridement), drug/alcohol abuse history in the last six months, and must be able to follow study procedures.Check my eligibility
What is being tested?
The Episealer Knee System clinical trial tests a surgical treatment for people with painful knee lesions due to osteoarthritis. It compares the effectiveness of the Episealer device against microfracture surgery in improving symptoms. The study randomly assigns participants to either receive the Episealer implant or undergo microfracture surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical surgical complications such as infection, bleeding, blood clots and reactions to anesthesia. There might also be device-specific issues like implant loosening or wear over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee pain is severe, and my overall knee function is poor.
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I have a knee injury with a specific size of damaged cartilage.
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I am between 30 and 70 years old.
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I have up to 2 painful cartilage defects in my knee suitable for Episealer treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-weeks, 8-weeks, 6-months, 12-months and 24-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-weeks, 8-weeks, 6-months, 12-months and 24-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Visual Analog Scale (VAS) Pain Scores
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores
Incidence of Secondary Surgical Intervention
+2 moreSecondary outcome measures
Change in 12-Item Short Form Survey (SF-12) score at all follow-up time points
Change in VAS Pain score at all follow-up time points
Change in the KOOS Subscores at all follow-up time points
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Episealer Knee SystemExperimental Treatment1 Intervention
The experimental arm will comprise of subjects that will be treated with the Episealer Knee System.
Group II: MicrofracturePlacebo Group1 Intervention
The control arm will comprise of subjects that will receive a Microfracture surgery.
Find a Location
Who is running the clinical trial?
MCRA, LLCIndustry Sponsor
18 Previous Clinical Trials
7,543 Total Patients Enrolled
2 Trials studying Osteoarthritis
115 Patients Enrolled for Osteoarthritis
Episurf Medical Inc.Lead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
MCRAIndustry Sponsor
29 Previous Clinical Trials
8,976 Total Patients Enrolled
2 Trials studying Osteoarthritis
115 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system condition or have been on medication that affects my immune system.I have another knee injury that could affect the study's assessment of my main knee issue.I have a history of rheumatoid arthritis.I have up to two cartilage defects between 1.5 and 4.0 cm2 each.I have a condition other than my knee issue that affects my ability to walk.My knee pain is severe, and my overall knee function is poor.You are allergic to the materials used in the implant, such as Cobalt-Chrome alloy and Titanium.You have a mental or psychological condition that would make it difficult for you to answer the study questionnaires.I have a knee injury with a specific size of damaged cartilage.I have tried non-surgical treatments like physical therapy for my knee pain for at least 4 weeks.My other knee has no conditions needing surgery that could affect my study knee's assessment.I am between 30 and 70 years old.Your bones are not strong enough for the experimental device to be securely attached.My lesion has poor blood supply, affecting healing.I had surgery on my knee using tissue or synthetic material within the last 6 months.My defect can't be fully covered by the Episealer device according to surgery measurements.My joint surface lesion lacks enough surrounding cartilage, as confirmed by my doctor.I have a bone defect between 4.0 and 7.0 cm2 suitable for the Episealer device.I don't have any health issues that would stop me from attending follow-up visits or doing post-op rehab.I have up to 2 painful cartilage defects in my knee suitable for Episealer treatment.You have an artificial joint in your knee or another joint.My affected knee can't bend or straighten as well as my other knee.I have health conditions that make surgery risky.My knee is unstable because of weak muscles or soft tissue.I do not meet any exclusion criteria based on surgery findings.I have advanced cartilage damage in my knee not being operated on.I have a condition or take medication that may affect bone healing.My knee injury is severe, either in the shinbone or kneecap.I need surgery to remove more than a third of my meniscus in the affected knee area.My knee X-ray shows significant joint space loss.I am not pregnant and do not plan to become pregnant in the next 2 years.This section does not apply as it is about exclusions before surgery.My knee is misaligned by more than 8 degrees.Your bones near the area of concern are not strong enough, according to the doctor's assessment.You have recently used drugs or alcohol excessively in the past 6 months.My condition does not meet any exclusion criteria during surgery.I do not have any current infections or a history of joint infections.
Research Study Groups:
This trial has the following groups:- Group 1: Episealer Knee System
- Group 2: Microfracture
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a vacancy within this research initiative for those seeking treatment?
"Affirmative. Perusal of clinicaltrials.gov reveals that this medical study, which first became available on June 18th 2020, is still open for recruitment. This experiment seeks 180 participants from 10 different trial sites."
Answered by AI
In what quantity of locations is this experiment being conducted?
"This trial is welcoming participants at 10 different sites, including QEII Health Sciences Center in Halifax, Nova Scotia; Horizon Clinical Research in La Mesa, California; and Clinical Research Solutions in Jackson, Tennessee."
Answered by AI
What is the aggregate number of participants in this medical experiment?
"This clinical trial necessitates 180 participants, as long as they meet the set inclusion criteria. Those who are interested can join from QEII Health Sciences Center in Halifax or Horizon Clinical Research in La Mesa."
Answered by AI
Is this trial enrolling adult participants?
"This research is searching for individuals who are over 30 years old and younger than 70 years of age."
Answered by AI
Do I qualify for inclusion in this research project?
"In order to be eligible for this medical trial, patients must possess healthy articular cartilage and fall between the ages of 30 and 70. The goal is to recruit a total of 180 participants."
Answered by AI
What objectives is this investigation attempting to fulfill?
"The primary objective of this two-year assessment is to measure the incidence of subsidence or migration. Subsidiary objectives include determining radiographic findings, tracking adverse events and device deficiencies, and evaluating changes in KOOS subscores at all follow-up time points."
Answered by AI
Who else is applying?
What site did they apply to?
Physicians Research Group
Ochsner Sports Medicine Institute
Hackensack University Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
Long term , intermittent pain. Orthopedist has recommended partial knee replacement.
PatientReceived 1 prior treatment
I've tried months of physical therapy, cortisone shots and hyalonic acid injections
If there is something else before total knee replacement, I'd like to try it.
PatientReceived no prior treatments
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