INSTRUCT for Repair of Knee Cartilage Defects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.

Detailed Description
-----------------
This is a prospective, open-label, single-arm pilot study designed to investigate the safety and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects. All patients who meet eligibility criteria and who consent to participate will undergo the implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells via arthrotomy. Patients will be followed-up for 2 years at regular intervals. Evaluations will include adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic and histologic evaluations and MRIs (including dGEMRIC).

Official Title
-----------------
Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects

Conditions
-----------------
Articular Cartilage Lesion of the Knee

Intervention / Treatment
-----------------
* Device: INSTRUCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a symptomatic articular cartilage defect in the knee Exclusion Criteria: Surgery on the study knee joint within 6 months Patients with significant malalignment (more than 5°) Patients with ligamentous instability of the knee Majority of the meniscus absent Severe osteoarthritis Intake of medications or treatments having an effect on bone or cartilage formation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INSTRUCT<br>INSTRUCT scaffold implantation | Device: INSTRUCT<br>* INSTRUCT PolyActive scaffold implantation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of related adverse events |  | Over 24 months | 
| Lesion filling |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of non-related adverse events |  | 24 months | 
| KOOS, IKDC and pain VAS scores |  | At all timepoints over 24 months | 
| Histopathology assessments |  | 6 or 12 months | 
| MRI evaluation of structural repair |  | Discharge, 3, 6, 12 and 24 months | 
| dGEMRIC assessment of structural repair |  | 6, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee cartilage defect repair, cartilage lesion, autologous chondrocyte, scaffold, INSTRUCT