Degenerative Lesion of Articular Cartilage of KneeNCT04000659

Episealer® Knee System IDE Clinical Study

A study testing Episealer Knee System and Microfracture in people with Degenerative Lesion of Articular Cartilage of Knee, run by Episurf Medical Inc. at 13 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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 up to two focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment. Read more about this study

Who is it for?: Ages 30 to 70 years
Conditions the study is for: Degenerative Lesion of Articular Cartilage of Knee
What is being tested?: Episealer Knee System and Microfracture
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 13 sitesin 4 countries
Study dates: 18 Jun 2020to Jun 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be ≥ 30 years and ≤ 70 years.
Have up to 2 symptomatic femoral chondral or osteochondral defects in the index knee on the medial or lateral femoral condyles or the knee trochlea area, which are:
ICRS Grade 2, 3 or Grade 4
Each suitable for treatment with 1 Episealer device NOTE: Additional femoral cartilage lesions which, in the opinion of the investigator, are asymptomatic and free from underlying bone lesions (e.g., bone edema) will not be treated.
Have focal articular defect(s) each with a cartilage lesion area ≥ 1.5 cm2 and ≤ 7.0 cm2.
Subjects with up to two defects ≥ 1.5 cm2 and ≤ 4.0 cm2, that are surrounded by adequate circumferential cartilage as determined by the investigator, will be randomized.

Show all 14Show fewer

Subjects with at least one defect > 4.0 cm2 and ≤ 7.0 cm2, with adequate bony support as determined by the investigator, will not be randomized, and will receive the Episealer device.
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 experienced knee pain symptoms and undergone prior non-surgical management (e.g., physical therapy, bracing, HA injections) for at least 4 weeks prior to being considered for the study.
Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
Be willing and able to comply with all study procedures including all pre-operative, post-operative, and rehabilitation requirements.
If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant in the next 24 months.

Who cannot join

Pre-Operative Exclusion Criteria
Subjects who meet any of the following pre-operative screening criteria will be excluded from participation in this study:
Have a Body Mass Index (BMI) greater than 37 kg/m2.
Have an ICRS Grade 3 or 4 tibial lesion of any size, or an ICRS Grade 4 patella lesion/fissure ≥ 2.0 mm in width in the index knee.
Have malalignment of >8 degrees varus or valgus in the index knee based on standard AP x-rays.
Have deficits in flexion or extension of >10 degrees in the index knee as compared to the contralateral knee.

Show all 38Show fewer

Have an existing prosthesis in the index knee compartment or opposing joint surface.
Have joint instability in the index knee due to soft tissue or muscular insufficiency.
Have a vascular insufficiency at the lesion site that will impair successful microfracture (e.g., avascular necrosis/osteonecrosis, osteochondritis dissecans). (NOTE: This exclusion will not apply to patients with lesions between 4.0-7.0 cm2 who will not undergo randomization and will be treated in the Episealer-only arm).
Have inadequate bone stock underlying the lesion site, in the opinion of the investigator.
Have any condition, therapy, or medication that may impair bone healing or prevent adequate implant fixation (e.g., osteoporosis).
Have a diagnosis of a concomitant knee injury, which in the opinion of the investigator, may confound assessment of the index knee.
Have any meniscus tears or defects that require resection of more than 1/3 of the meniscus in the compartment to be treated (i.e., medial meniscus when medial femoral compartment is being treated; lateral meniscus when lateral femoral compartment is being treated).
Have a contralateral knee with symptomatic cartilage, meniscal, or ligamentous lesions; generalized osteoarthritis, or any condition that requires surgery, which in the opinion of the investigator, may confound assessment of the index knee, or any condition that requires surgery.
Have any condition that is unrelated to the index knee and significantly impairs walking ability (e.g., spinal stenosis, sciatica).
Have undergone previous treatment with autograft or allograft transfer, synthetic plugs, or microfracture in the index knee within 6 months of screening. (NOTE: Subjects who have undergone debridement at any point in the past are not excluded).
Have a loss of joint space on standing radiographs (Kellgren-Lawrence Grade ≥3) in the index knee.
Have an active systemic infection, or an active local infection in or near the index knee, or a previous history of joint infection.
Have a history of rheumatoid arthritis.
Have known allergies to any of the materials used in the implant (i.e., Cobalt-Chrome alloy and Titanium).
Have a contraindication to MRI (e.g., implanted pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, stent, implanted electronic infusion pumps or any other condition that would prevent the subject from undergoing an MRI).
Have a known immunodeficiency including subjects who are receiving or have received corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery.
Are participating in another clinical investigation for which they received an investigational product (including, but not limited to, a drug or vaccine) within the last 60 days or report the intention to participate in another clinical investigation during the course of the study
Are currently abusing drugs or alcohol or have a history of the same within the last 6 months.
Have any mental or psychological disorder that would impair their ability to complete the study questionnaires.
Are currently breastfeeding or planning to breastfeed any time during the course of the study.
Are currently a prisoner.
Have significant comorbidities or conditions associated with high-risk for surgical or anesthetic survival (e.g., renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
Have any medical condition or other circumstances, in the judgment of the investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative rehabilitation.
Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance.
Intra-operative Exclusion Criteria
Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:
Have any meniscus tears or defects that require resection of more than 1/3 of the meniscus in the compartment to be treated (i.e., medial meniscus when medial femoral compartment is being treated; lateral meniscus when lateral femoral compartment is being treated).
Have chondrosis of the non-operative patellofemoral compartment, contralateral compartment or medial or lateral proximal tibia greater than Outerbridge Grade 2.
Have an index lesion on the articular surface that lacks adequate circumferential cartilage as determined by the investigator (NOTE: This exclusion applies only to patients randomized to the microfracture arm.)
Applicable to Investigational Group Only
Have a defect undergoing treatment that cannot be adequately covered by the Episealer device based on intra-operative measurements.
Have bone quality which, in the judgment of the surgeon, would prevent satisfactory fixation of the investigational device.

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

United States8 sites

Ohio State University
Columbus, Ohio, 43202
North Texas Medical Research Institute
Dallas, Texas, 75254
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Helios Clinical Research
Jackson, Tennessee, 38305
Horizon Clinical Research
La Mesa, California, 91942
Ochsner Sports Medicine Institute
New Orleans, Louisiana, 70121
Plancher Orthopaedics & Sports Medicine
New York, New York, 10128
Physicians Research Group
Tempe, Arizona, 85284

Other trials in United States

Germany2 sites

Universitatsmedizin Berlin Charite
Berlin, 10117
Orthocentrum Hamburg
Hamburg, 20149

Other trials in Germany

United Kingdom2 sites

University Hospital Coventry and Warwickshire NHS Trust
Coventry, England, CV2 2DX
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD

Other trials in United Kingdom

Canada1 site

QEII Health Sciences Center
Halifax, Nova Scotia, B3H 2E1

Other trials in Canada

About this study

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

Read the 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 up to 2 focal femoral chondral or osteochondral lesions 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.

Conditions: Degenerative Lesion of Articular Cartilage of Knee
Being tested: Episealer Knee System, Microfracture
Keywords: Knee, Cartilage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Episealer Knee SystemDevice
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.
MicrofractureProcedure or surgery
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.

Study groups in NCT04000659
Study group	Role	What they receive
Episealer Knee System	Experimental	The experimental arm will comprise of subjects that will be treated with the Episealer Knee System. Receives: Device: Episealer Knee System
Microfracture	Placebo comparator	The control arm will comprise of subjects that will receive a Microfracture surgery. Receives: Procedure: Microfracture

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores
This endpoint will examine the change in KOOS subscores at 24 months
Measured: 24 Months
Change in Visual Analog Scale (VAS) Pain Scores
This endpoint will examine the change in VAS Pain scores at 24 months
Measured: 24 Months
Incidence of Secondary Surgical Intervention
This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months
Measured: 24 Months
Incidence of subsidence or migration at 24 months
This endpoint will examine the incidence of subsidence/migration at 24 months
Measured: 24 Months
Weight bearing status
This endpoint will examine the weight bearing status at 8 weeks
Measured: 8 weeks

Secondary outcomes (5)

Change in the KOOS Subscores at all follow-up time points
This endpoint will examine the change in KOOS subscores at all follow-up time points
Measured: 3-weeks, 8-weeks, 6-months, 12-months, and 24-months
Change in VAS Pain score at all follow-up time points
This endpoint will examine the change in VAS Pain scores at all follow-up time points
Measured: 3-weeks, 8-weeks, 6-months, 12-months, and 24-months
Change in 12-Item Short Form Survey (SF-12) score at all follow-up time points
This endpoint will examine the change in SF-12 scores at all follow-up time points
Measured: 3-weeks, 8-weeks, 6-months, 12-months, and 24-months
Incidence of radiographic findings at all follow-up time points
This endpoint will examine the incidence of radiographic findings at all follow-up time points
Measured: 8 weeks, 12-months, and 24-months
Incidence of adverse events and device deficiencies at all follow-up time points
This endpoint will examine the safety via the incidence of adverse events and device deficiencies at all follow-up time points
Measured: 3-weeks, 8-weeks, 6-months, 12-months and 24-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 2020Jun 2029

First posted27 Jun 2019
Study start18 Jun 2020
Primary completionJun 2028 (estimated)
Study completionJun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Degenerative Lesion of Articular Cartilage of KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04000659
Sponsor's protocol ID: IDE 1006
Status last verified: Oct 2026
First submitted: 10 Jun 2019
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04000659
Acronym / sponsor ID: IDE 1006
Conditions: Degenerative Lesion of Articular Cartilage of Knee
Keywords: Knee, Cartilage
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 13 participants (actual)
Lead sponsor: Episurf Medical Inc.Industry (pharma, biotech, devices)
Collaborators: MCRA
Study start: 18 Jun 2020 (actual)
Primary completion: Jun 2028 (estimated)
Study completion: Jun 2029 (estimated)
First posted: 27 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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.

Arm	Type	Receives
Episealer Knee System	Experimental	Device: Episealer Knee SystemThe experimental arm will comprise of subjects that will be treated with the Episealer Knee System.
Microfracture	Placebo comparator	Procedure: MicrofractureThe control arm will comprise of subjects that will receive a Microfracture surgery.

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Be ≥ 30 years and ≤ 70 years.
Have up to 2 symptomatic femoral chondral or osteochondral defects in the index knee on the medial or lateral femoral condyles or the knee trochlea area, which are:
Have focal articular defect(s) each with a cartilage lesion area ≥ 1.5 cm2 and ≤ 7.0 cm2.
Have screening scores that meet the following criteria:
Have experienced knee pain symptoms and undergone prior non-surgical management (e.g., physical therapy, bracing, HA injections) for at least 4 weeks prior to being considered for the study.

Key exclusion criteria (38 listed)

Pre-Operative Exclusion Criteria
Subjects who meet any of the following pre-operative screening criteria will be excluded from participation in this study:
Have a Body Mass Index (BMI) greater than 37 kg/m2.
Have an ICRS Grade 3 or 4 tibial lesion of any size, or an ICRS Grade 4 patella lesion/fissure ≥ 2.0 mm in width in the index knee.
Have malalignment of >8 degrees varus or valgus in the index knee based on standard AP x-rays.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Episealer Knee SystemThe 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.	Device	Episealer Knee System
MicrofractureMicrofracture 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.	Procedure or surgery	Microfracture

Primary outcome

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
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
Incidence of Secondary Surgical Intervention
Time frame: 24 Months
This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months
Incidence of subsidence or migration at 24 months
Time frame: 24 Months
This endpoint will examine the incidence of subsidence/migration at 24 months
Weight bearing status
Time frame: 8 weeks
This endpoint will examine the weight bearing status at 8 weeks

5 secondary outcomes

Change in the KOOS Subscores at all follow-up time points
Time frame: 3-weeks, 8-weeks, 6-months, 12-months, and 24-months
Change in VAS Pain score at all follow-up time points
Time frame: 3-weeks, 8-weeks, 6-months, 12-months, and 24-months
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
Incidence of radiographic findings at all follow-up time points
Time frame: 8 weeks, 12-months, and 24-months
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katarina Flodström study director

Episurf Medical Inc.

13 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Episealer Knee System and Microfracture in people with Degenerative Lesion of Articular Cartilage of Knee, run by Episurf Medical Inc. at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Germany, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores (time frame: 24 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04000659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.