Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 10, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Rotator Cuff Tendinopathy
Interventions
DEVICE

Polynucleotides (Tropho Tend)

"Tropho Tend is administered by injecting the solution at level of muscular-tendineal (MJT) or osteo-tendineal junctions (OTJ) using a fine-gauge needle (usually 25-30G).~Before injecting the product, the target area will be disinfected with alcohol or another antiseptic, with the antiseptic removed with physiologic sterile solution.~Total number of treatments will consist in 3 Tropho Tend administrations: at T0 - basal visit;~* T1 - after 2 weeks;~* T3 - after 4 weeks."

PROCEDURE

Rehabilitation physiotherapy

Rehabilitation physiotherapy (standard of care)

Trial Locations (1)

41049

RECRUITING

Ospedale di Sassuolo S.p.A., Sassuolo

All Listed Sponsors
lead

Mastelli S.r.l

INDUSTRY