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Tolerance of intra-articular injection of autologous stromal vascular fraction for the treatment of rhizarthrosis_FVS-RHIZA

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515317-18-00
Acronym
2018/0419/HP
Enrollment
10
Registered
2024-09-24
Start date
2023-10-26
Completion date
Unknown
Last updated
2025-01-24

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

Conditions

Adults with a rhizarthrosis stage DELL 1 to 3

Brief summary

The number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS

Detailed description

Assess at 1, 3 and 6 months functional assessment of the hand (Kapandji score, JAMAR and Key pinch, Active mobility of the trapezio-metacarpal in antepulsion and abduction, Grinding test, DASH and PWRHE quick score), Assess at 1, 3 and 6 months the pain by the EVA scale and by monitoring the progress of long-term analgesic treatment, Assess at 1, 3 and 6 months cartilage regeneration (Evaluation by MRI of the cartilage and X-ray of the trapezio-metacarpal, Assessment of adverse events using EvI/EvIG data collection

Interventions

Sponsors

Centre Hospitalier Universitaire Rouen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS

Secondary

MeasureTime frame
Assess at 1, 3 and 6 months functional assessment of the hand (Kapandji score, JAMAR and Key pinch, Active mobility of the trapezio-metacarpal in antepulsion and abduction, Grinding test, DASH and PWRHE quick score), Assess at 1, 3 and 6 months the pain by the EVA scale and by monitoring the progress of long-term analgesic treatment, Assess at 1, 3 and 6 months cartilage regeneration (Evaluation by MRI of the cartilage and X-ray of the trapezio-metacarpal, Assessment of adverse events using EvI/EvIG data collection

Countries

France

Outcome results

None listed

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