Episealer Knee System vs Microfracture Surgery for Osteoarthritis

Recruiting at 17 trial locations

Overseen By Scott Hacker, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Episurf Medical Inc.

Must not be taking: Corticosteroids, Immunosuppressants, Immunostimulants, others

Disqualifiers: Obesity, Osteoporosis, Rheumatoid arthritis, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee treatment, the Episealer Knee System, against standard microfracture surgery for individuals with knee pain from damaged cartilage. The researchers aim to determine if the Episealer Knee System more effectively reduces pain and improves knee function. The trial targets individuals with knee pain from up to two damaged cartilage spots that have not improved with non-surgical treatments like physical therapy. Participants must have tried other non-surgical methods and still experience significant knee pain affecting their daily life. As an unphased trial, this study offers participants the opportunity to explore a potentially more effective treatment option for knee pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medications that impair bone healing or have received corticosteroids or immunosuppressants within 6 months prior to surgery, you may be excluded from the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Episealer Knee System is likely safe. Two studies found significant improvements in patients two years after surgery, with a low failure rate of just 2.5%. Another study confirmed good-to-excellent short-term safety and positive outcomes for patients. These findings suggest that the Episealer Knee System is generally well-tolerated, making it a potentially safe option for treating knee problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Episealer Knee System is unique because it offers a personalized implant solution specifically designed to fit each patient's knee, unlike traditional treatments like microfracture surgery that rely on stimulating cartilage growth by creating small fractures in the bone. This system targets the damaged area with precision, potentially reducing pain and improving joint function more effectively. Researchers are excited about this treatment because it could provide a less invasive and more durable option for people with knee osteoarthritis, offering a quicker recovery and possibly delaying or eliminating the need for more extensive surgery like knee replacement.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research has shown that the Episealer Knee System, which participants in this trial may receive, can greatly improve knee function and reduce pain for people with certain types of knee damage. In recent studies, patients experienced significant improvement two years after surgery, with a low failure rate of 2.5%. Another study found that the implants lasted well, with 92.6% still functioning after ten years. These findings suggest that the Episealer Knee System is a promising option for those with specific knee issues related to osteoarthritis. The trial will also compare these outcomes to those of participants receiving Microfracture surgery, a standard articular cartilage repair technique. ^{1 2 3 5 6}

Who Is on the Research Team?

Katarina Flodström

Principal Investigator

Episurf Medical Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have up to two cartilage defects between 1.5 and 4.0 cm2 each.

My knee pain is severe, and my overall knee function is poor.

I have a knee injury with a specific size of damaged cartilage.

Exclusion Criteria

Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical treatment with either the Episealer Knee System or Microfracture surgery

8 weeks

Multiple visits for surgical procedure and initial recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic assessments and pain score evaluations

24 months

Regular follow-up visits at 3 weeks, 8 weeks, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Episealer Knee System
• Microfracture

Trial Overview 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.

How Is the Trial Designed?

Group I: Episealer Knee System Experimental Treatment 1 Intervention

The experimental arm will comprise of subjects that will be treated with the Episealer Knee System.

Group II: Microfracture Placebo Group 1 Intervention

The control arm will comprise of subjects that will receive a Microfracture surgery.

Who Is Running the Clinical Trial?

Episurf Medical Inc.

Lead Sponsor

Trials

3

Recruited

50+

MCRA, LLC

Industry Sponsor

Trials

19

Recruited

7,500+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Published Research Related to This Trial

In a 5-year study of patients receiving multiple courses of hylan G-F 20 injections for osteoarthritis knee pain, the incidence of local adverse events (AEs) increased with each treatment course, from 3.4% in the first course to 17.3% in the third course.

Most local AEs were mild to moderate and lasted less than 48 hours, suggesting that while there is a slight increase in risk with repeated treatments, the benefits of pain relief from hylan G-F 20 may outweigh the risks for many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hylan G-F 20 tolerability with repeat treatment in a large orthopedic practice: a retrospective review. Waddell, DD., Bricker, DC.[2006]

In a study of over 1.3 million epidural corticosteroid injections (ESIs) from 2009 to 2015, the rate of serious spinal adverse events (SSAEs) was found to be low at 8.1 per 1,000,000 patients.

Cervical and thoracic ESIs were associated with a significantly higher risk of SSAEs (29.4 per 1,000,000) compared to lumbar and sacral injections (5.1 per 1,000,000), while the risk was similar across different corticosteroid formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious spinal adverse events associated with epidural corticosteroid injections in the Medicare population. Eworuke, E., Crisafi, L., Liao, J., et al.[2022]

Enhanced microfracture procedures for treating focal cartilage injuries in the knee significantly improve patient-reported outcomes, indicating effectiveness in symptom relief, based on a review of 10 studies with 331 patients.

However, imaging results were inconsistent, and the reporting of treatment-related adverse events was inadequate, suggesting that while the procedure shows promise, further research is needed to fully endorse its use for grade III/IV cartilage lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced microfracture using acellular scaffolds improves results after treatment of symptomatic focal grade III/IV knee cartilage lesions but current clinical evidence does not allow unequivocal recommendation. da Cunha, CB., Andrade, R., Veloso, TR., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10050034/

Patient-specific resurfacing implant knee surgery ... Two recent studies showed significant clinical improvement at 24 month post-surgery, good implant safety and low failure rate of 2.5% [6, 15]. Although ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04000659

NCT04000659 | Episealer® Knee System IDE Clinical Study Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores, This endpoint will examine the change in KOOS subscores at 24 months, 24 Months.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0968016024000310

Focal resurfacing of the knee – A systematic review and ... However, in one series a Kaplan-Meir survival as high as 92.6% at a 10-year follow-up period was noted. A statistically significant improvement was documented ...

4. odtmag.com odtmag.com/breaking-news/study-shows-improved-patient-outcomes-for-episealer-knee-implant/

Study Shows Improved Patient Outcomes for Episealer Knee ... In total, 30 patients are included in the study and the average follow-up time is 55 months (24 to 86 months). The Episealer Knee implant is ...

5. episurf.com episurf.com/files/PMR1004_Episealer-Knee-Clinical-Summary_V01.pdf

EPISEALER® KNEE CLINICAL SUMMARY Surgery (CAOS) shows promising results for both total and partial joint replacement. ... the latest follow-up were compared with the baseline data for the Knee ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2059775425006315

Satisfactory survivorship and clinical outcomes up to 10 ... Statistically significant improvements in all clinical scores (VAS, KOOS, IKDC) were observed between baseline and two years and then remained ...