cartilage defect/ cartilage lesion
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to measure the level of clinical improvement and quality of life at 6, 12 and 18 months. This is assessed by, subscales of, the KOOS and the EQ5D, respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to measure functional repair using MRI at 6 and 18 months postoperative. | — |
Countries
Netherlands
Outcome results
None listed