INSTRUCT for Repair of Knee Cartilage Defects

February 2, 2015 updated by: CellCoTec B.V.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INSTRUCT
INSTRUCT scaffold implantation
INSTRUCT PolyActive scaffold implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of related adverse events
Time Frame: Over 24 months
Over 24 months
Lesion filling
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Joël Guidoux, CellCoTec B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 31, 2009

First Submitted That Met QC Criteria

December 31, 2009

First Posted (Estimate)

January 1, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Articular Cartilage Lesion of the Knee

3
Subscribe