Episealer Knee System vs Microfracture Surgery for Osteoarthritis

Recruiting at 17 trial locations

Overseen By Deryk Jones, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Episurf Medical Inc.

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

13 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the Episealer Knee System and Microfracture treatment for osteoarthritis?

Microfracture surgery, when combined with proper rehabilitation, has been shown to be effective for pain relief and improving function in patients with knee osteoarthritis. It is a preferred initial surgical treatment for osteoarthritis, especially in younger patients where joint replacement is not suitable. ^{1 2 3 4 5}

Is the Episealer Knee System or Microfracture Surgery safe for treating osteoarthritis?

The safety of intra-articular therapies for knee osteoarthritis, like those used in the Episealer Knee System, shows a very low incidence of adverse events, which are mostly mild and self-limited, such as pain and swelling. However, the quality of safety evidence is low, and better monitoring and reporting are needed. ^{6 7 8 9 10}

How does the Episealer Knee System treatment differ from microfracture surgery for osteoarthritis?

The Episealer Knee System is a unique treatment for osteoarthritis that involves a personalized implant designed to fit the specific defect in the knee, unlike microfracture surgery which involves creating small holes in the bone to stimulate cartilage growth. This personalized approach may offer a more tailored solution compared to the more generalized technique of microfracture. ^{1 2 3 11 12}

Research Team

Katarina Flodström

Principal Investigator

Episurf Medical Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of osteoarthritis of the knee with microfracture and rehabilitation. [2012]

3. Germany pubmed.ncbi.nlm.nih.gov

[Microfracture and specific rehabilitation for treating osteoarthritis of the knee. Indications, surgical technique, and rehabilitation protocol]. [2012]

4. Germany pubmed.ncbi.nlm.nih.gov

Microfracture for cartilage repair in the knee: a systematic review of the contemporary literature. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Results at 10-14 years after microfracture treatment of articular cartilage defects in the knee. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The safety of intra-articular injections for the treatment of knee osteoarthritis: a critical narrative review. [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

Epidural steroid injection-related events requiring hospitalisation or emergency room visits among 52,935 procedures performed at a single centre. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Incidence of inadvertent intra-articular lumbar facet joint injection during fluoroscopically guided interlaminar epidural steroid injection. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Risk of serious spinal adverse events associated with epidural corticosteroid injections in the Medicare population. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Comparison of curative effect between osteochondral mosaic transplantation and micro-fracture in the treatment of knee joint articular cartilage injury]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Histomorphological Investigation of Microfracture Location in a Rabbit Osteochondral Defect Model. [2023]