Focal Cartilage LesionsEpisealerNCT04808700
Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
A study testing Follow-up of Episealer implant in people with Focal Cartilage Lesions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Lesions in the cartilage are common disorders. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Cartilage Lesions
- What is being tested?
- Follow-up of Episealer implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Dec 2028
- 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 of 18 years old (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. The maximum size of the lesion is set at 6cm².
- Informed consent obtained
Who cannot join
- 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
Lesions in the cartilage are common disorders. 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.
In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing)
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).
In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing).
- Conditions
- Focal Cartilage Lesions
- Being tested
- Follow-up of Episealer implant
- Keywords
- Cartilage lesions, Episealer implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up of Episealer implantOther
Follow-up and radiographic evaluation in patients who received an Episealer implant
| Study group | Role | What they receive |
|---|---|---|
| Focal cartilage lesion | Other | Patients with focal cartilage lesions who underwent a knee surgery using the Episealer implant Receives: Other: Follow-up of Episealer implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic and clinical evaluation
Survival of the implant up to 24 months post treatment with loss of the primary implant
Measured: within a time frame of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startJan 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Cartilage LesionsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hillde Vandenneucker, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808700
- Sponsor's protocol ID
- S57685
- Acronym
- Episealer
- Status last verified
- Nov 2024
- First submitted
- 17 Mar 2021
- Last updated
- 8 Nov 2024
- 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
- ClinicalTrials.gov ID
- NCT04808700
- Acronym / sponsor ID
- Episealer / S57685
- Conditions
- Focal Cartilage Lesions
- Keywords
- Cartilage lesions, Episealer implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Mar 2021 (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.
Lesions in the cartilage are common disorders. 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.
In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing)
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).
In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal cartilage lesion | Other | Other: Follow-up of Episealer implantPatients with focal cartilage lesions who underwent a knee surgery using the Episealer implant |
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 of 18 years old (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. The maximum size of the lesion is set at 6cm².
- Informed consent obtained
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Follow-up of Episealer implantFollow-up and radiographic evaluation in patients who received an Episealer implant | Other | Focal cartilage lesion |
Primary outcome
Radiographic and clinical evaluation
Time frame: within a time frame of 2 years
Survival of the implant up to 24 months post treatment with loss of the primary implant
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 8 Nov 2024.
- Individual participant dataSharing planned: No
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Degenerative Lesion of Articular Cartilage of Knee
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Management of Focal Cartilage Lesions of the Knee: The Benefits of an Autograft Procedure
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Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella
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Cartilage Lesion
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.
Hillde Vandenneucker principal investigator
Universitaire Ziekenhuizen KU 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 Follow-up of Episealer implant in people with Focal Cartilage Lesions, 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 6 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 8 Nov 2024. 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?
Radiographic and clinical evaluation (time frame: within a time frame of 2 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 8 Nov 2024.