Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome

Launched by GUNA S.P.A · Aug 3, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a new collagen-based medical device called MD-Shoulder Collagen, designed to treat Rotator Cuff Syndrome, which is a common shoulder problem causing pain and difficulty in movement. The study aims to see if this device can help improve shoulder function and reduce pain in individuals who have been experiencing shoulder pain for at least three months due to conditions like rotator cuff tendinopathy or partial tendon injuries.

To participate in this trial, individuals must be 18 years or older, have shoulder pain for at least three months, and have a specific level of shoulder function as measured by the Constant Murley Score. However, those with complete rotator cuff tears, certain shoulder conditions, or various health issues like diabetes or allergies to porcine collagen are not eligible. Participants will receive the collagen treatment and will be monitored to see how their shoulder function and pain levels change over time. This study is currently recruiting participants and aims to provide new insights into effective treatments for shoulder pain.

Gender

ALL

Eligibility 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.