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

NCT06809543 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-02

No results posted yet for this study

Summary

This is a prospective, open label, controlled, exploratory clinical investigation aimed to evaluate the clinical benefit and safety of Tropho Tend in the conservative management of painful Rotator Cuff Tendinopathy (RCT).

All subjects will be involved in the clinical investigation for 4 months for a total of 5 visits (T0= basal visit, T1, T2, T3, T4).

The control group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy (standard of care).

The therapy group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy + TrophoTend perilesional injection (TrophoTend will be added on to current standard of care).

All the screened patients at the baseline visit (T0), after checking the inclusion/exclusion criteria, will be prospectively included in the clinical investigation, in a 1:1 randomization. Patients will be randomly assigned to the "control group" (N=30pts), receiving rehabilitation physiotherapy (standard of care), or to the "therapy group" (N=30 pts), receiving Tropho Tend as a add on therapy to the rehabilitation physiotherapy.

Total duration of Clinical Investigation will be 12 months: 2-4 months for patients screening and enrolment; 1 month of therapy administration (3 perilesional injections 2 weeks apart); 3 months of follow-up; 2-4 months for data analysis and final report/paper elaboration.

At the baseline visit (T0), an ultrasound evaluation (EUS) has to be performed to assess tendon condition. If an EUS evaluation performed within one month from T0 is available, this will be considered acceptable. This first evaluation has to be compared with another EUS performed at the final visit to obtain a qualitative description of the ultrasound appearance of the tendon after the treatment.

Patients' enrolment will take 2-4 months. Tropho Tend will be administrated at T0 (basal visit) at T1 (2 weeks) and at T2 (4 weeks) for a total duration of treatment of 1 month.

Follow-up will be performed at T3 (8 weeks) and T4 (12 weeks= 3 months). End of the clinical investigation will be considered the last visit for the last enrolled patient.

A 40% reduction in mean VAS scores between the "Tropho Tend therapy group" and the "control group" is considered as reflecting meaningful clinical improvement for the patient.

At the final visit, the patient has to rate his/her satisfaction with the treatment using a 5-points Likert scale, where 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=highly satisfied.

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)

Sponsors & Collaborators

  • Mastelli S.r.l

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06809543 on ClinicalTrials.gov