INSTRUCT for Repair of Knee Cartilage Defects

Articular Cartilage Lesion of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041885
• Other study ID #: 309-019
• Status: Completed
• Phase: N/A
• First received: December 31, 2009
• Last updated: February 2, 2015
• Start date: January 2010
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: CellCoTec B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Articular Cartilage Lesion of the Knee

Intervention

Device:
• INSTRUCT
INSTRUCT PolyActive scaffold implantation

Locations

Country	Name	City	State
Belgium	University Hospital Gent	Gent
Poland	University Hospital nber 2 Dr. Jana Biziela	Bydgoszcz
Poland	NZOZ "Szpital AVIMED" sp. z o.o.	Katowice
Poland	NZOZ Endomedical	Poznan
Poland	Centrum Medycyny Sportowej (Sports Medicine Center CMS)	Warsaw
United Kingdom	Royal Orthopaedic Hospital	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
CellCoTec B.V.

Countries where clinical trial is conducted

Belgium,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of related adverse events		Over 24 months	Yes
Primary	Lesion filling		3 months	No
Secondary	Incidence of non-related adverse events		24 months	Yes
Secondary	KOOS, IKDC and pain VAS scores		At all timepoints over 24 months	No
Secondary	Histopathology assessments		6 or 12 months	No
Secondary	MRI evaluation of structural repair		Discharge, 3, 6, 12 and 24 months	No
Secondary	dGEMRIC assessment of structural repair		6, 12 and 24 months	No