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.

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. - ACTIVE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50832

Enrollment

Registered

2021-10-28

Start date

2022-03-02

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage defect cartilage lesion

Interventions

Knee surgery using the Hydrogel to fill the defect.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Subject is at least 18 years and maximum 50 years of age at time of consent; 2. Subject presents with a symptomatic defect in the knee with an NRS pain score of 4 or more; 3. Subject presents with defect(s) in the knee cartilage with ICRS classification grades IIIa or IIIb; 4. Subject has a contained lesion(s) of between 0.5 - 2 cm2 in size, and it is localized on the femoral condyle or trochlea; if there are multiple defects, the sum of all sizes should not be more than 2 cm2;; 5. Subject has an intact (ICRS grade

Exclusion criteria

Exclusion criteria: 1. Subject has a BMI > 30 kg/m2; 2. Subject underwent index-knee surgery 1 as determined from recent (

Design outcomes

Primary

Measure	Time frame
Safety: • Incidence, nature and severity of procedure and/or device related adverse events up to 3 months post-surgery. Performance: • Change from baseline in the composite (average of the 5 subscales) KOOS at 12 months post-surgery.	—

Secondary

Measure	Time frame
The following secondary outcome measures will be captured during both the safety and performance phases of the study: Imaging measures: • Determine the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) II score at 12, 24 and 60 months post-surgery. Patient reported outcome measures: • Change from baseline in the composite KOOS at 3 and 6 months post-surgery . • Change from baseline in the KOOS subscale scores (pain, other symptoms, function in daily living, function in sport and recreation and knee related quality of life) at 3-, 6-, 12-, 24-, 36-, 48-, and 60 -months post-surgery . • Change from baseline in the EuroQol-5-dimension-5L (EQ-5D-5L) health questionnaire at 3-, 6-, 12-, 24-, 36-, 48-, and 60 -months post-surgery . • Change from baseline in health-related quality of life as measured by the 36-Item Short-Form Health Survey version 2 (SF-36) scores at 3-, 6-, 12-, 24-, 36-, 48-, and 60 -months post-surgery . • Change in the Numeric (pain) Rating Scale (NRS) score from baseline at the following time-points post-surgery 1 day, 1 week, 1-, 3-, 6-, 12-, 24-, 36-, 48-, and 60 -months post-surgery . Physical impairment measures: • Knee range of motion (ROM) at 1, 3, 6 and 12 months post-surgery. Other measures: • Ease of use by surgeons, as measured with a VAS rating scale . • Proportion of patients requiring further intervention or treatment to the affected knee during the 12-month follow-up period.	—

Measure

Time frame

The following secondary outcome measures will be captured during both the safety and performance phases of the study: Imaging measures: • Determine the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) II score at 12, 24 and 60 months post-surgery. Patient reported outcome measures: • Change from baseline in the composite KOOS at 3 and 6 months post-surgery . • Change from baseline in the KOOS subscale scores (pain, other symptoms, function in daily living, function in sport and recreation and knee related quality of life) at 3-, 6-, 12-, 24-, 36-, 48-, and 60 -months post-surgery . • Change from baseline in the EuroQol-5-dimension-5L (EQ-5D-5L) health questionnaire at 3-, 6-, 12-, 24-, 36-, 48-, and 60 -months post-surgery . • Change from baseline in health-related quality of life as measured by the 36-Item Short-Form Health Survey version 2 (SF-36) scores at 3-, 6-, 12-, 24-, 36-, 48-, and 60 -months post-surgery . • Change in the Numeric (pain) Rating Scale (NRS) score from baseline at the following time-points post-surgery 1 day, 1 week, 1-, 3-, 6-, 12-, 24-, 36-, 48-, and 60 -months post-surgery . Physical impairment measures: • Knee range of motion (ROM) at 1, 3, 6 and 12 months post-surgery. Other measures: • Ease of use by surgeons, as measured with a VAS rating scale . • Proportion of patients requiring further intervention or treatment to the affected knee during the 12-month follow-up period.

—

Countries

Netherlands

Contacts

Public ContactK Ruiter

Universitair Medisch Centrum Utrecht

k.ruiter-4@umcutrecht.nl+31887569349

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026