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

Official title

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

Overview

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.

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)

Primary outcome measures

• Variation of pain and functional impairment [Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment]
• Variation of Shoulder pain and disability index (SPADI) between the 2 groups [Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment]
• Single assessment numeric evaluation (SANE) [Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment]

Secondary outcome measures (4)

• Patient's satisfaction [Time frame: From the second visit (T1) to last follow-up after 12 weeks from end of treatment]
• Qualitative description of the ultrasound appearance of the tendon [Time frame: Baseline and last follow-up visit (T4)]
• Quality of Life using EQ-5D-3L Paper Self-Complete [Time frame: Baseline and at the two follow-up visits (at T3 - 8 weeks after the end of the treatment and T4 - 12 weeks after the end of the treatment)]
• Adverse events (AE) monitoring [Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment]

Eligibility criteria

Inclusion criteria

• Male and female patients ≥ 18 years of age, in good general health condition.
• Painful Rotator Cuff Tendinopathy (RCT) since ≥ 6 weeks.
• Pain and impaired functionality on a 0 to 10 cm-centimeter specifically designed Visual Analogue Scale (VAS) ≥ 4 cm at baseline visit.
• Rotator Cuff Tendinopathy (RCT) diagnosis, based on clinical examination.
• Tendon ultrasound (EUS) performed within one month of enrollment.
• Signed written informed consent.

Exclusion criteria

• Treatment with any investigational product within 6 months prior to clinical investigation entry.
• Patients with known hypersensitivity to the products (active compound and excipients) or any component or procedure used in the clinical investigation.
• Patients with para-tendinopathy, partial/total rupture, previous tendon surgery.
• Severe intercurrent illness (e.g.: uncontrolled diabetes mellitus, peripheral neuropathy, autoimmune or inflammatory condition, metabolic disorders, severe oncological conditions) that, in the opinion of the investigator, may put the patient at risk when participating in the clinical investigation or affect the patient's ability to take part in the clinical investigation .
• Patients treated with systemic and/or local steroids within the last 6 months, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours.
• Recent history of drug and/or alcohol abuse (within the last 6 months).
• Pregnant or breastfeeding women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Ospedale di Sassuolo S.p.A. — Sassuolo

Publications

• Colangelo MT, Govoni P, Belletti S, Squadrito F, Guizzardi S, Galli C. Polynucleotide biogel enhances tissue repair, matrix deposition and organization. J Biol Regul Homeost Agents. 2021 Jan-Feb;35(1):355-362. doi: 10.23812/20-320-L. No abstract available. PMID 33480222
• Saggini R, Khodor HH, Capogrosso F, Carniel R, Bellomo RG. La condro-sincronizzazione nel danno articolare complesso: risultati della viscosupplementazione con Condrotide. Journal of viscosupplementation.it 2016; 2(1): 1-7.
• Saggini R, Di Stefano A, Capogrosso F, Carniel R, Haidar Hassan K, et al. (2014) Viscosupplementation with Hyaluronic Acid or Polynucleotides: Results and Hypothesis for Condro-synchronization. J Clin Trials 4: 198. doi:10.4172/2167-0870.1000198

Identifiers

NCT: NCT06809543 · Tropho-Try-2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗