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Sterile allogeneic spongioflex® allografts as partial meniscal replacement after incomplete meniscal loss, an investigator-initiated trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508271-36-00
Enrollment
30
Registered
2024-03-15
Start date
2024-04-30
Completion date
Unknown
Last updated
2025-11-16

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

Conditions

incomplete meniscal loss

Brief summary

Improvement of PROMs (KOOS, IKDC, VAS Pain Score) 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores.

Detailed description

Safety of the patient: Type, frequency and severity of treatment-related AEs and SAEs, Efficacy of the procedure: How many patients show a progression of osteoarthrosis up to TKA?, MRI evaluation: Outerbridge graduation, size of meniscus, number of patients with extrusion, size of extrusion after 6 weeks, 6 and 12 months (for operated patients) and after 2 and 5 years, comparison between the operated and the non-operated group, Patient satisfaction: very pleased, pleased, not pleased, very unsatisfied in the operated group after 2 and 5 years

Interventions

DRUGHUMAN CANCELLOUS BONE

Sponsors

Dr. Sven Behrendt, Knie und Schulterchirurgie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Improvement of PROMs (KOOS, IKDC, VAS Pain Score) 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores.

Secondary

MeasureTime frame
Safety of the patient: Type, frequency and severity of treatment-related AEs and SAEs, Efficacy of the procedure: How many patients show a progression of osteoarthrosis up to TKA?, MRI evaluation: Outerbridge graduation, size of meniscus, number of patients with extrusion, size of extrusion after 6 weeks, 6 and 12 months (for operated patients) and after 2 and 5 years, comparison between the operated and the non-operated group, Patient satisfaction: very pleased, pleased, not pleased, very unsatisfied in the operated group after 2 and 5 years

Countries

Germany

Outcome results

None listed

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