Prospective monocenter study on clinical outcomes and safety of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee

Phase 2

Withdrawn

Conditions: cartilage defect/ cartilage lesion
10043237

Registration Number: NL-OMON46367

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 50

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 and <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 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

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to measure the level of clinical improvement and<br /><br>quality of life at 6, 12 and 18 months. This is assessed by, subscales of, the<br /><br>KOOS and the EQ5D, respectively.</p><br>

Secondary Outcome Measures