Non-inferiority of surgical treatment of cartilage defects of the knee with autologous minced cartilage implantation (AMCI) and matrix-asscociated autologous chondrocyte implantation with respect to KOOS at 24 months (M ACI) - MinCaRCT

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526179-49-00

Enrollment

166

Registered

2026-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Full-thickness cartilage defects of the knee

Brief summary

The primary efficacy endpoint is the KOOS5 (composite Knee injury and Osteoarthritis Outcome Score) at 24 months after randomisation

Detailed description

Following scores and questionnaires at 3, 6, 12, 24 months after randomisation: IKDC, KOOS5, KOOS subscales (Pain, Symptoms, ADL, Sport and Recreation, QOL), Lysholm, QOL SF-12, absence from work and incidence and number of revision surgeries.

Interventions

DRUGMACI 500

DRUG000 to 1

DRUG000

DRUG000 cells/cm2 implantation matrix

DRUGSpherox 10-70 spheroids/cm2 implantation suspension

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the KOOS5 (composite Knee injury and Osteoarthritis Outcome Score) at 24 months after randomisation	—

Secondary

Measure	Time frame
Following scores and questionnaires at 3, 6, 12, 24 months after randomisation: IKDC, KOOS5, KOOS subscales (Pain, Symptoms, ADL, Sport and Recreation, QOL), Lysholm, QOL SF-12, absence from work and incidence and number of revision surgeries.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 4, 2026