What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly surgical interventions like the Episealer Knee System, include arthroscopic surgery, partial meniscectomy, and debridement. Known side effects of these surgical treatments can include infection, deep venous thrombosis, and complications related to anesthesia. Non-surgical treatments such as NSAIDs (e.g., ibuprofen, naproxen) can cause gastrointestinal issues, cardiovascular risks, and kidney problems. Intraarticular glucocorticoid injections, used for short-term pain relief, may lead to joint infection, increased pain, and potential cartilage damage with repeated use.

What prior FDA approvals exist?

The FDA has approved various treatments for osteoarthritis, including surgical options like total knee replacement and other implant-based procedures. While the Episealer Knee System is a specific surgical implantation for repairing chondral or osteochondral lesions, other similar treatments include partial knee replacements and cartilage repair techniques. These procedures aim to alleviate pain and improve joint function by addressing the damaged areas directly. There are no specific drugs approved by the FDA that mimic the surgical implantation approach of the Episealer Knee System.

What other types of research exist?

Promising alternatives to the Episealer Knee System for osteoarthritis patients include: 1) Autologous Nasal Chondrocyte Transplantation (N-TEC), which has shown reduced pain and improved joint function in patients with advanced OA. 2) Unicompartmental Knee Arthroplasty, which offers quicker recovery and improved range of motion compared to total knee arthroplasty, though with a higher chance of reoperation. 3) Woven Carbon Surface Replacement, which has demonstrated pain relief and functional improvement in patients with early osteoarthritis without causing inflammatory changes or joint deterioration.

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Orthopedic Implant

Episealer Knee System vs Microfracture Surgery for Osteoarthritis

N/A

Waitlist Available

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.

Must not have

Have a history of rheumatoid arthritis.

Have any condition that is unrelated to the index knee and significantly impairs walking ability (e.g., spinal stenosis, sciatica).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-weeks, 8-weeks, 6-months, 12-months and 24-months

Summary

This trial is testing a knee implant called the Episealer Knee System on patients with specific knee damage causing pain or disability. The implants aim to repair the damaged areas, improving knee function and reducing pain.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of rheumatoid arthritis.

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I have a condition other than my knee issue that affects my ability to walk.

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I had surgery on my knee using tissue or synthetic material within the last 6 months.

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My defect can't be fully covered by the Episealer device according to surgery measurements.

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My affected knee can't bend or straighten as well as my other knee.

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I have health conditions that make surgery risky.

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My knee is unstable because of weak muscles or soft tissue.

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I do not meet any exclusion criteria based on surgery findings.

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I have advanced cartilage damage in my knee not being operated on.

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My knee injury is severe, either in the shinbone or kneecap.

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I need surgery to remove more than a third of my meniscus in the affected knee area.

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My knee X-ray shows significant joint space loss.

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My knee is misaligned by more than 8 degrees.

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I do not have any current infections or a history of joint infections.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-weeks, 8-weeks, 6-months, 12-months and 24-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Visual Analog Scale (VAS) Pain Scores

Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores

Incidence of Secondary Surgical Intervention

+2 more

Secondary study objectives

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 more

Trial 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.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Osteoarthritis (OA) include analgesics like acetaminophen, which reduce pain by inhibiting pain signals; NSAIDs such as ibuprofen and naproxen, which reduce inflammation and pain by blocking COX enzymes; and glucocorticoids, which provide short-term pain relief by reducing inflammation. Surgical interventions, such as the Episealer Knee System, focus on repairing damaged cartilage or bone in the knee. This is particularly important for OA patients with significant joint damage, as it aims to restore joint function and reduce pain, potentially delaying the need for more extensive surgeries like total knee replacement.