SINEFIX-2022 Comparative Phase

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2028

Conditions
Rotator Cuff Tears of the Shoulder
Interventions
DEVICE

Rotator cuff repair with the SINEFIX

Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments

DEVICE

Rotator cuff repair with comparator device

Treatment of rotator cuff lesions with the conventional surgical technique (comparator device)

Trial Locations (2)

53894

Kreiskrankenhaus Mechernich GmbH (KKHM), Mechernich

72074

Orthopädisch Chirurgisches Centrum (OCC), Tübingen

Sponsors
All Listed Sponsors
lead

BAAT Medical Products B.V.

INDUSTRY