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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01041885

Enrollment

Registered

2010-01-01

Start date

2010-01-31

Completion date

2014-06-30

Last updated

2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Articular Cartilage Lesion of the Knee

Keywords

knee cartilage defect repair, cartilage lesion, autologous chondrocyte, scaffold, INSTRUCT

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).

Interventions

DEVICEINSTRUCT

INSTRUCT PolyActive scaffold implantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of related adverse events	Over 24 months
Lesion filling	3 months

Secondary

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

Countries

Belgium, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026