INSTRUCT for Repair of Knee Cartilage Defects
Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects
1 other identifier
interventional
40
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2009
CompletedFirst Posted
Study publicly available on registry
January 1, 2010
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 4, 2015
February 1, 2015
2.7 years
December 31, 2009
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of related adverse events
Over 24 months
Lesion filling
3 months
Secondary Outcomes (5)
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
Study Arms (1)
INSTRUCT
EXPERIMENTALINSTRUCT scaffold implantation
Interventions
Eligibility Criteria
You may qualify if:
- Patients with a symptomatic articular cartilage defect in the knee
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CellCoTec B.V.lead
Study Sites (6)
University Hospital Gent
Ghent, Belgium
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, Poland
Royal Orthopaedic Hospital
Birmingham, United Kingdom
Related Publications (1)
Slynarski K, de Jong WC, Snow M, Hendriks JAA, Wilson CE, Verdonk P. Single-Stage Autologous Chondrocyte-Based Treatment for the Repair of Knee Cartilage Lesions: Two-Year Follow-up of a Prospective Single-Arm Multicenter Study. Am J Sports Med. 2020 May;48(6):1327-1337. doi: 10.1177/0363546520912444. Epub 2020 Apr 8.
PMID: 32267734DERIVED
Study Officials
- STUDY DIRECTOR
Joël Guidoux
CellCoTec B.V.
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 31, 2009
First Posted
January 1, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2012
Study Completion
June 1, 2014
Last Updated
February 4, 2015
Record last verified: 2015-02