Cartilage DamageEpisealer2NCT03755388
Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
A study testing Episealer in people with Cartilage Damage and Knee Injuries, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The goal of this study is to evaluate the efficacy, safety and performance of the Episealer® device in a sample size of 30 patients and on the long term (10 years follow-up). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cartilage Damage, Knee Injuries
- What is being tested?
- Episealer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Sep 2018to Dec 2034
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible
- Minimal age 18 years (Preferred age group >40 years)
- Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion.
- Informed consent
Who cannot join
- Under age (<18yrs)
- Active or recent (<1 yr) septic arthritis of the involved knee
- Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee
- (Severe) osteoarthritis in the involved or other compartments of the involved knee
- Severe osteoporosis
- MRI not possible (eg. due to pacemaker)
- Marked valgus- or varus alignment (>6 degrees)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
The goal of this study is to evaluate the efficacy, safety and performance of the Episealer® device in a sample size of 30 patients and on the long term (10 years follow-up).
Read the detailed description
Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the medial femoral condyle. The quality of life of patients with focal cartilage defects is significantly affected and it has been shown that the quality of life is affected to the same extend as in patients scheduled for knee replacement. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis.
Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. The implant and surgical instruments are customized to each patient's joint anatomy, position, and size of injury, based on patient-specific images (MRI). The Episealer® device is CE marked.
The Episealer® implant consists of a peg and a hat. The implant exists in five different diameters (12,14,17, 20 and 25mm), depending on the lesion size. The shape of the hat is circular or oval.
The Episealer® implant is made of biocompatible cobalt/chromium/molybdenum alloy. To enhance the osseointegration, the implant is coated with biocompatible hydroxyapatite onto an interlaying biocompatible pure titanium coating.
A previous study (S57685) showed that Episealer is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing). This device is a good solution when there are no alternative treatments, except prosthesis surgery, available.
The goal is to evaluate the efficacy, safety and performance of the Episealer® device in a larger sample size and on the long term.
- Conditions
- Cartilage Damage, Knee Injuries
- Being tested
- Episealer
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpisealerDevice
Placing Episealer device
| Study group | Role | What they receive |
|---|---|---|
| Episealer group | Experimental | Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible Receives: Device: Episealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Presence of the implant in the patient up to 10 years post treatment with loss/revision of the primary implant as endpoint
Measured: 10 years
Secondary outcomes (4)
Radiographic measurements
Efficacy will be evaluated with the comparison of the pre- and post- operative radiographs
Measured: 10 years
Knee injury and Osteoarthritis Outcome Score (KOOS)
Performance will be evaluated with the comparison of the pre- and post- operative KOOS-scores. Scoring: each item is scored between 0 and 4 and the raw score of each section is the sum or item scores. The score is then converted into a 0-100 scale. A higher score indicates fewer problems
Measured: 10 years
Visual Analogue Scale (VAS) pain
Performance will be evaluated with the comparison of the pre- and post- operative VAS-scores. Score between 0 and 10. Higher score indicates more pain.
Measured: 10 years
Complications
Safety will be evaluated by monitoring AEs, unanticipated device effects and subsequent interventions through 10 years post treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start20 Sep 2018
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DamageStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilde Vandenneucker, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755388
- Sponsor's protocol ID
- S61896
- Acronym
- Episealer2
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2018
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
- ClinicalTrials.gov ID
- NCT03755388
- Acronym / sponsor ID
- Episealer2 / S61896
- Conditions
- Cartilage Damage, Knee Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 28 Nov 2018 (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.
The goal of this study is to evaluate the efficacy, safety and performance of the Episealer® device in a sample size of 30 patients and on the long term (10 years follow-up).
Detailed description
Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the medial femoral condyle. The quality of life of patients with focal cartilage defects is significantly affected and it has been shown that the quality of life is affected to the same extend as in patients scheduled for knee replacement. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis.
Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. The implant and surgical instruments are customized to each patient's joint anatomy, position, and size of injury, based on patient-specific images (MRI). The Episealer® device is CE marked.
The Episealer® implant consists of a peg and a hat. The implant exists in five different diameters (12,14,17, 20 and 25mm), depending on the lesion size. The shape of the hat is circular or oval.
The Episealer® implant is made of biocompatible cobalt/chromium/molybdenum alloy. To enhance the osseointegration, the implant is coated with biocompatible hydroxyapatite onto an interlaying biocompatible pure titanium coating.
A previous study (S57685) showed that Episealer is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing). This device is a good solution when there are no alternative treatments, except prosthesis surgery, available.
The goal is to evaluate the efficacy, safety and performance of the Episealer® device in a larger sample size and on the long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Episealer group | Experimental | Device: EpisealerSubjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible
- Minimal age 18 years (Preferred age group >40 years)
- Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion.
- Informed consent
Key exclusion criteria (7 listed)
- Under age (<18yrs)
- Active or recent (<1 yr) septic arthritis of the involved knee
- Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee
- (Severe) osteoarthritis in the involved or other compartments of the involved knee
- Severe osteoporosis
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 |
|---|---|---|
| EpisealerPlacing Episealer device | Device | Episealer group |
Primary outcome
Survival
Time frame: 10 years
Presence of the implant in the patient up to 10 years post treatment with loss/revision of the primary implant as endpoint
4 secondary outcomes
Radiographic measurements
Time frame: 10 years
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 10 years
Visual Analogue Scale (VAS) pain
Time frame: 10 years
Complications
Time frame: 10 years
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Hilde Vandenneucker, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episealer in people with Cartilage Damage and Knee Injuries, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 7 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 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. 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?
Survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.