INSTRUCT for Repair of Knee Cartilage Defects

Not Applicable

Completed

• Conditions: Articular Cartilage Lesion of the Knee
• Interventions: Device: INSTRUCT

• Registration Number: NCT01041885
• Lead Sponsor: CellCoTec B.V.

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).

Study Timeline

• Study First Submitted: 2009-12-31
• Study First Submitted QC: 2009-12-31
• Study Start: 2010-01
• Study First Posted: 2010-01-01
• Primary Completion: 2012-09
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INSTRUCT	INSTRUCT	INSTRUCT scaffold implantation

Primary Outcome Measures

Name	Time	Method
Incidence of related adverse events	Over 24 months
Lesion filling	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

University Hospital Gent; 🇧🇪 Gent, Belgium

Royal Orthopaedic Hospital; 🇬🇧 Birmingham, United Kingdom

Centrum Medycyny Sportowej (Sports Medicine Center CMS); 🇵🇱 Warsaw, Poland

University Hospital nber 2 Dr. Jana Biziela; 🇵🇱 Bydgoszcz, Poland

NZOZ Endomedical; 🇵🇱 Poznan, Poland

NZOZ "Szpital AVIMED" sp. z o.o.; 🇵🇱 Katowice, Poland