Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect

NCT05186935 | Unknown DMC

• 1 other identifier: 19019-Hy2Care-CIP01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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'.

Conditions

Cartilage Damage

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months follow up

Secondary Outcomes (1)

• Cartilage Regeneration via Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)

  12 months

Study Arms (1)

Single arm

EXPERIMENTAL

This is a multi-center, pivotal, non-randomized, prospective, open-label clinical investigation.

Device: Injectable Hydrogel treatment

Interventions

Injectable Hydrogel treatment DEVICE

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.

Single arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.
• 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;

Sponsors & Collaborators

• Hy2Care BV: lead
• Avania: collaborator
• UMC Utrecht: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Study Officials

• Roel Custers, Dr

  UMCU - Academic Hospital Utrecht

  PRINCIPAL INVESTIGATOR

• Barbara Kalkman, Dr

  UMCU - Academica Hospital Utrecht

  STUDY DIRECTOR

Central Study Contacts

Sanna Severins, MSc

CONTACT

+31(0)88 999 5700; sanna.severins@hy2care.com

Sanne Both, Dr

CONTACT

+31(0)88 999 5700; sanne.both@hy2care.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: February 28, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)