Randomized controlled trial on clinical outcomes and safety of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee

Phase 3

Completed

• Conditions: cartilage defect/ cartilage lesion; 10043237

• Registration Number: NL-OMON55402
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Provides written informed consent, is able to understand the content of the
study, understands the requirements for follow-up visits and is willing to
provide the required information at follow-up visits and in the questionnaires.
- Symptomatic articular cartilage lesion of the knee (femoral condyles or
trochlea).
- Age 18 to 45 years old
- Modified Outerbridge Grade III or IV isolated cartilage lesion of the knee.
- A post-debridement size of the cartilage lesion > 2cm2 and <= 8 cm2
- At least 50% of functional meniscus remaining. Meniscal repair or resection
is allowed during the IMPACT surgery provided that the surgeon is able to
confirm that at least 50% of functional meniscus remains.
- Stable knee ligaments (i.e. anterior and posterior cruciate ligaments).

Exclusion Criteria

- Malalignment of >5 degrees
- (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as
determined from appropriate X-ray.
- Concomitant inflammatory disease that affects the joint (rheumatoid
arthritis, metabolic bone disease, psoriasis, gout, symptomatic
chondrocalcinosis)
- (History of) Septic arthritis.
- (History of) Total menisectomy in the target knee joint.
- Any surgery in the knee joint for cartilage treatment, 6 months prior to
study inclusion.
- Risk groups for MRI scanning due to the magnetic field like patients with
pacemakers, nerve stimulators, metal particles, stents, clips or implants,
(possible) pregnancy or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified