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

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 - IMPACT2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55402

Enrollment

Registered

2018-10-10

Start date

2019-07-23

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

cartilage defect/ cartilage lesion

Interventions

Onestage surgery using the Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT)

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 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

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 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.

Design outcomes

Primary

Measure	Time frame
The primary objective is to measure the level of clinical improvement and quality of life at 3, 6, and 9 months compared to conservative treatment. 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

Source: NL-OMON (via WHO ICTRP)