Cartilage DamageACTIVENCT05186935
Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect
A study testing Injectable Hydrogel treatment in people with Cartilage Damage, run by Hy2Care BV at 1 site in Netherlands.
Trial summary
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care") to treat cartilage defects (< 2 cm2) in the human knee. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cartilage Damage
- What is being tested?
- Injectable Hydrogel treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Feb 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is at least 18 years and maximum 50 years of age at time of surgery;
- Subject presents with a symptomatic defect in the knee with an NRS pain score of 4 or more;
- Subject presents with defects in the knee cartilage with ICRS classification grades IIIa or IIIb;
- Subject has a contained lesion of between 0.5 - 2 cm2 in size, and it is localized on the femoral condyle or trochlea;
- Subject has an intact (ICRS grade ≤ 1) articulating joint surface (without "kissing lesions");
- Subject is willing and able to comply with all aspects of the treatment, including MRI, after-care rehabilitation and evaluation schedule over a 12-month duration; and
- Subject is willing and able to provide documented Ethics Committee-approved informed consent prior to initiation of any study procedures.
Who cannot join
- Subject has a BMI > 30 kg/m2;
- Subject has multiple defects to be treated that are interconnected or that have less than 0.5 cm of space in between them;
- Subject underwent index-knee surgery < 3 months prior to study treatment.
- Subject suffers from any medical condition that would hinder cartilage repair, such as additional unresolved comorbidities related to the index knee:
- Untreated anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) deficiency or,
- Complex ligamentous instability of the knee/ insufficient ligament support,
Show all 19Show fewer
- Meniscus lesions, total or partial (more than 1/2 of total volume) resected meniscus,
- Limited joint mobility,
- Varus/valgus joint malalignment of more than 3 degrees,
- Subject has a trochlear cartilage defect that is associated with (suspected) patella maltracking without surgical correction,
- Subject underwent previous (failed) cartilage repair procedure(s), such as microfracture (MF), Osteochondral Autograft Transplantation (OATS) or Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee.
- Comorbidities that are resolved during the same surgical procedure as the investigational device treatment, do not qualify for this exclusion criterion.
- Subject has (history of) generalized osteoarthritis, defined as Kellgren-Lawrence grade >1 as determined from recent (<6 months at time of enrollment) X-ray;
- Subject suffers from inflammatory joint diseases (e.g. rheumatoid arthritis, Bechterew disease, chondromatosis);
- Subjects suffers from autoimmune disease, vascular or neurological disease;
- Subject suffers from an active or recent local or systematic infection, or has a history of knee infections;
- Subject has an active malignant tumor at the time of treatment;
- Subject has hypersensitivity or allergy to the constituents of the product.
- Pregnant or lactating women at the time of enrollment or women who are planning to become pregnant during the duration of the study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584 CX
Barbara Kalkman, Dr., B.M.Kalkman@umcutrecht.nl
Roel Custers, Dr
About this study
Official title: A Multi-center, Pivotal, Non-randomized, Prospective, Open-label Study to Evaluate the Safety and Performance of the Hy2Care Injectable Hydrogel for the Repair of Cartilage Defects in the Knee
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care") to treat cartilage defects (< 2 cm2) in the human knee. The product aims at functional repair of cartilage defects in the knee and regeneration of cartilage.
The objective of this clinical investigation is to demonstrate the clinical safety and performance of the Hy2Care Injectable hydrogel. Data from this clinical investigation will be used to support a CE marking application for the Hy2Care Injectable hydrogel.
Sites will be selected based on a documented site qualification procedure. The Principal Investigator at each site will be selected based on confirmed expertise in the orthopaedic field. Each site will have a designated Principal Investigator and one or more study coordinators collectively responsible for the study data collection, inclusive of screening, enrolment, evaluation and documentation, in accordance with the International Organization for Standardization (ISO) 14155 guidelines for Good Clinical Practice. Per site, one physician will be assigned as Principal Investigator. Other physicians will be referred to as 'sub-investigators'.
Read the detailed description
This is a multi-center, pivotal, non-randomized, prospective, open-label clinical investigation.
Safety oversight throughout will be provided by an independent Data Monitoring Committee (DMC) comprised of a clinical expert (knee surgeon), medical monitor and a senior statistician.
The clinical investigation will be split into two cohorts:
Safety cohort: The safety cohort is intended to determine the primary safety of the investigational device. In this cohort, 10 subjects will be treated at preferably 1 site. The safety cohort will receive the investigational device intraoperatively.
Following implantation of the investigational device in the initial safety cohort, the DMC will continuously monitor all emerging safety issues against the defined stopping rules of the clinical investigation. Any treatment-emergent severe adverse events or other safety concerns during the safety phase of the clinical investigation will immediately be referred, on a case by case basis, to the DMC for review against the stopping rules.
A formal review of safety against the stopping rules will be undertaken by the DMC when all of the safety cohort patients reach 3 months post- surgery. Subjects will be followed post-operatively for 12 months. The subjects in the safety cohort will undergo the same procedures as in the performance cohort, therefore all data acquired for the safety cohort will also be used to measure the performance and safety endpoints defined for the performance cohort.
Performance cohort: The performance cohort is intended to demonstrate the safety and performance of the investigational device. This cohort will be initiated after the completion of the safety phase and approval from the DMC. In the performance cohort 36 subjects will be treated at up to 5 investigational sites, where they will receive the investigational device intraoperatively.
The sample size has been calculated based on a minimal clinically important change (MIC) of 10 points in the composite Knee Injury and Osteoarthritis Outcome Score (KOOS, a patient reported outcome measure), compared to baseline, to provide an assessment of the performance of the investigational device. The primary endpoint is at 12 months follow-up. All subjects will be followed post-operatively for 12 months. Additional assessments occur at 1 month, 3 months and 6 months post-surgery.
- Conditions
- Cartilage Damage
- Being tested
- Injectable Hydrogel treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Hydrogel treatmentDevice
The Injectable Hydrogel is a single use two-component injectable and bioresorbable hydrogel intended for treatment of cartilage defects in the knee, it is a medical device, exclusively for clinical investigations. The hydrogel is mixed intraoperatively and with an open knee procedure inserted into the cartilage defect, where it crosslinks and adheres to the cartilage with the use of a primer, allowing it to stay in place during movements of the knee. The hydrogel covers the defect to prevent formation of scar tissue and to allow cartilage to regenerate. The Injectable Hydrogel will be used in combination with general instruments typically used. The different components of the Injectable Hydrogel are arranged in two boxes: Components of the Injectable Hydrogel are grouped in plastic cover bags or packaged in vial boxes.This is a performance study, with a single arm, i.e Injectable Hydrogel. Recovery is monitored.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | This is a multi-center, pivotal, non-randomized, prospective, open-label clinical investigation. Receives: Device: Injectable Hydrogel treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Change from baseline in the composite (average of the 5 subscales) Knee Injury and OsteoArthritis Outcome Score (KOOS) at 12 months post-surgery.
Performance:
- Change from baseline in the composite (average of the 5 subscales) Knee Injury and OsteoArthritis Outcome Score (KOOS), at 12 months post-surgery.
Hypothesis: Average change from baseline in the composite Knee Injury and OsteoArthritis Outcome Score (KOOS) at 12 months post-surgery with Hy2Care Injectable hydrogel is greater than a minimal clinically important change (MIC) of 10.
Measured: 12 months follow up
Secondary outcomes (1)
Cartilage Regeneration via Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
Determine the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) II score at 12 months post-surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start28 Feb 2022 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hy2Care BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania, UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Roel Custers, Dr, Principal investigator, UMCU - Academic Hospital UtrechtBarbara Kalkman, Dr, Study director, UMCU - Academica Hospital Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186935
- Sponsor's protocol ID
- 19019-Hy2Care-CIP01
- Acronym
- ACTIVE
- Status last verified
- Feb 2022
- First submitted
- 23 Dec 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Pivotal, Non-randomized, Prospective, Open-label Study to Evaluate the Safety and Performance of the Hy2Care Injectable Hydrogel for the Repair of Cartilage Defects in the Knee
- ClinicalTrials.gov ID
- NCT05186935
- Acronym / sponsor ID
- ACTIVE / 19019-Hy2Care-CIP01
- Conditions
- Cartilage Damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hy2Care BVIndustry (pharma, biotech, devices)
- Collaborators
- Avania, UMC Utrecht
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 11 Jan 2022 (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.
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care") to treat cartilage defects (< 2 cm2) in the human knee. The product aims at functional repair of cartilage defects in the knee and regeneration of cartilage.
The objective of this clinical investigation is to demonstrate the clinical safety and performance of the Hy2Care Injectable hydrogel. Data from this clinical investigation will be used to support a CE marking application for the Hy2Care Injectable hydrogel.
Sites will be selected based on a documented site qualification procedure. The Principal Investigator at each site will be selected based on confirmed expertise in the orthopaedic field. Each site will have a designated Principal Investigator and one or more study coordinators collectively responsible for the study data collection, inclusive of screening, enrolment, evaluation and documentation, in accordance with the International Organization for Standardization (ISO) 14155 guidelines for Good Clinical Practice. Per site, one physician will be assigned as Principal Investigator. Other physicians will be referred to as 'sub-investigators'.
Detailed description
This is a multi-center, pivotal, non-randomized, prospective, open-label clinical investigation.
Safety oversight throughout will be provided by an independent Data Monitoring Committee (DMC) comprised of a clinical expert (knee surgeon), medical monitor and a senior statistician.
The clinical investigation will be split into two cohorts:
Safety cohort: The safety cohort is intended to determine the primary safety of the investigational device. In this cohort, 10 subjects will be treated at preferably 1 site. The safety cohort will receive the investigational device intraoperatively.
Following implantation of the investigational device in the initial safety cohort, the DMC will continuously monitor all emerging safety issues against the defined stopping rules of the clinical investigation. Any treatment-emergent severe adverse events or other safety concerns during the safety phase of the clinical investigation will immediately be referred, on a case by case basis, to the DMC for review against the stopping rules.
A formal review of safety against the stopping rules will be undertaken by the DMC when all of the safety cohort patients reach 3 months post- surgery. Subjects will be followed post-operatively for 12 months. The subjects in the safety cohort will undergo the same procedures as in the performance cohort, therefore all data acquired for the safety cohort will also be used to measure the performance and safety endpoints defined for the performance cohort.
Performance cohort: The performance cohort is intended to demonstrate the safety and performance of the investigational device. This cohort will be initiated after the completion of the safety phase and approval from the DMC. In the performance cohort 36 subjects will be treated at up to 5 investigational sites, where they will receive the investigational device intraoperatively.
The sample size has been calculated based on a minimal clinically important change (MIC) of 10 points in the composite Knee Injury and Osteoarthritis Outcome Score (KOOS, a patient reported outcome measure), compared to baseline, to provide an assessment of the performance of the investigational device. The primary endpoint is at 12 months follow-up. All subjects will be followed post-operatively for 12 months. Additional assessments occur at 1 month, 3 months and 6 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Injectable Hydrogel treatmentThis is a multi-center, pivotal, non-randomized, prospective, open-label clinical investigation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is at least 18 years and maximum 50 years of age at time of surgery;
- Subject presents with a symptomatic defect in the knee with an NRS pain score of 4 or more;
- Subject presents with defects in the knee cartilage with ICRS classification grades IIIa or IIIb;
- Subject has a contained lesion of between 0.5 - 2 cm2 in size, and it is localized on the femoral condyle or trochlea;
- Subject has an intact (ICRS grade ≤ 1) articulating joint surface (without "kissing lesions");
Key exclusion criteria (19 listed)
- Subject has a BMI > 30 kg/m2;
- Subject has multiple defects to be treated that are interconnected or that have less than 0.5 cm of space in between them;
- Subject underwent index-knee surgery < 3 months prior to study treatment.
- Subject suffers from any medical condition that would hinder cartilage repair, such as additional unresolved comorbidities related to the index knee:
- Comorbidities that are resolved during the same surgical procedure as the investigational device treatment, do not qualify for this exclusion criterion.
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 |
|---|---|---|
| Injectable Hydrogel treatmentThe Injectable Hydrogel is a single use two-component injectable and bioresorbable hydrogel intended for treatment of cartilage defects in the knee, it is a medical device, exclusively for clinical investigations. The hydrogel is mixed intraoperatively and with an open knee procedure inserted into the cartilage defect, where it crosslinks and adheres to the cartilage with the use of a primer, allowing it to stay in place during movements of the knee. The hydrogel covers the defect to prevent formation of scar tissue and to allow cartilage to regenerate. The Injectable Hydrogel will be used in combination with general instruments typically used. The different components of the Injectable Hydrogel are arranged in two boxes: Components of the Injectable Hydrogel are grouped in plastic cover bags or packaged in vial boxes.This is a performance study, with a single arm, i.e Injectable Hydrogel. Recovery is monitored. | Device | Single arm |
Primary outcome
Performance
Time frame: 12 months follow up
Change from baseline in the composite (average of the 5 subscales) Knee Injury and OsteoArthritis Outcome Score (KOOS) at 12 months post-surgery. Performance: • Change from baseline in the composite (average of the 5 subscales) Knee Injury and OsteoArthritis Outcome Score (KOOS), at 12 months post-surgery. Hypothesis: Average change from baseline in the composite Knee Injury and OsteoArthritis Outcome Score (KOOS) at 12 months post-surgery with Hy2Care Injectable hydrogel is greater than a minimal clinically important change (MIC) of 10.
1 secondary outcome
Cartilage Regeneration via Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- 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.
Roel Custers, Dr principal investigator
UMCU - Academic Hospital Utrecht
Barbara Kalkman, Dr study director
UMCU - Academica Hospital Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable Hydrogel treatment in people with Cartilage Damage, run by Hy2Care BV at 1 site in Netherlands.
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 7 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanna Severins, MSc (+31(0)88 999 5700, sanna.severins@hy2care.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: 12 months follow up). 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 22 Feb 2022.