Evaluation of a collagen device for treating rotator cuff syndrome
Performance and Safety Evaluation of Type I Collagen (MD-Shoulder Collagen Medical Device) in the Treatment of Rotator Cuff Syndrome ''ROPIRAMED PILOT STUDY''
NA · Guna S.p.a · NCT05489484
This study is testing a new collagen device to see if it can help people with rotator cuff syndrome feel less pain and recover better over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guna S.p.a (industry) |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT05489484 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the performance and safety of the MD-Shoulder Collagen Medical Device in patients suffering from Rotator Cuff Syndrome. The study will enroll 24 subjects who have experienced shoulder pain for at least three months and will evaluate their recovery and pain reduction using the Constant Murley Score at multiple time points over a 12-month treatment period. Participants will be monitored for analgesic consumption and any adverse effects related to the treatment. The study will be conducted at a single center in Milan, Italy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with shoulder pain lasting at least three months and a diagnosis of rotator cuff tendinopathy or partial injuries.
Not a fit: Patients with complete rotator cuff lesions or those with other specific shoulder conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved shoulder function for patients with rotator cuff syndrome.
How similar studies have performed: While there is ongoing interest in biological therapies for tendon injuries, this specific approach using a collagen device is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with age \> 18 years. * Subjects with shoulder pain for at least 3 month. * Subjects with a diagnosis of rotator cuff tendinopathy, subacromial conflict syndrome, partial rotator cuff tendon injuries (injuries A and B according to Snyder's Classification). * Subjects with a CMS score between 40 and 75. * Subjects who understood and signed the Informed Consent to Active Participation in the study. * Subjects able to understand the conditions of the study and participate throughout the duration. Exclusion Criteria: * Subjects with complete rotator cuff lesions (C lesions according to Snyder's classification). * Subjects with shoulder instability. * Subjects with adhesive retractile capsulitis. * Subjects undergoing Hyaluronic Acid and/or cortisone infiltration in a period \< 3 months. * Subjects with diabetes mellitus. * Subjects with uncontrolled thyroid disease. * Subjects with coagulopathies. * Subjects on chronic treatment with immunosuppressants. * Subjects with an allergy to porcine collagen. * Subjects in pregnancy or lactation.
Where this trial is running
Milan, MI
- Gaetano Pini CTO — Milan, MI, Italy (RECRUITING)
Study contacts
- Principal investigator: Randelli RP Pietro Simone, Prof — Gaetano Pini CTO
- Study coordinator: Miranda MV Vincenzo, Dr
- Email: v.miranda@guna.it
- Phone: 3351311917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tendinitis, Syndrome Rotator Cuff, Tendinopathy, Tendinoses, Rotator Cuff, Rotator Cuff Injuries, Collagen Type I, MD-Shoulder Collagen Medical Device, Shoulder