NCT05186935

Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hy2Care BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Cartilage Damage

Interventions

Type	Name	Description
DEVICE	Injectable Hydrogel treatment	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.

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2022-01-11
• Last updated: 2022-02-22

Locations

1 site across 1 country: Netherlands