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Randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis with nasal chondrocyte-based tissue engineered cartilage implantation vs current standard of care (ENCANTO)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513683-25-00
Acronym
n.a.
Enrollment
122
Registered
2025-06-10
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-17

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

Conditions

Patellofemoral osteoarthritis

Brief summary

Change in KOOS-5 subjective score from baseline to the 24-month follow-up

Detailed description

Mean KOOS subscores at all timepoints (baseline, 6, 12 and 24 months), Kujala Anterior Knee Pain Scale at 6, 12 and 24 months, WOMAC Score at baseline, 6, 12 and 24 months, EQ-5D-5L at baseline 6, 12 and 24 months, GROC likert scale at baseline, 6, 12 and 24 months, Marx Activity Rating Scale at baseline, 6, 12 and 24 months, VAS Score at baseline, 6, 12 and 24 months, Patient Satisfaction Questionnaire at 24 months, MRI at baseline, 6, 12 and 24 months, X-ray at baseline, 6, 12 and 24 months, Safety (number of SARs and SUSARs), Number of treatment failures at 24 months

Interventions

DRUGN-TEC

Sponsors

Universitaetsspital Basel
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in KOOS-5 subjective score from baseline to the 24-month follow-up

Secondary

MeasureTime frame
Mean KOOS subscores at all timepoints (baseline, 6, 12 and 24 months), Kujala Anterior Knee Pain Scale at 6, 12 and 24 months, WOMAC Score at baseline, 6, 12 and 24 months, EQ-5D-5L at baseline 6, 12 and 24 months, GROC likert scale at baseline, 6, 12 and 24 months, Marx Activity Rating Scale at baseline, 6, 12 and 24 months, VAS Score at baseline, 6, 12 and 24 months, Patient Satisfaction Questionnaire at 24 months, MRI at baseline, 6, 12 and 24 months, X-ray at baseline, 6, 12 and 24 months, Safety (number of SARs and SUSARs), Number of treatment failures at 24 months

Countries

Austria, Croatia, Germany, Italy, Netherlands, Poland, Sweden

Outcome results

None listed

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