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

NCT ID: NCT05489484

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-04
• Study Completion Date: 2025-03-29

Brief Summary

Rotator Cuff Syndrome is a commonly encountered musculoskeletal disorder in clinical practice, with an incidence ranging from 0.3% to 5.5%, and an annual prevalence of 0.5% to 7.4%. In addition, over time, with a monthly rate of 0.26%, this condition can progress to complete rotator cuff tendon injury resulting in worsening pain and shoulder function. The etiology of Rotator Cuff Syndrome is still controversial. What the investigators know is that in tendinopathies there are histological changes in the structure of the tendons, resulting in a change in the mechanical properties of the tendons and leading to a chronic often disabling pain condition. Although conservative therapy should still be considered the first choice in cuff tendinopathies, The clinical results of the various types of nonsurgical treatments are still mixed and often show poor efficacy. This explains the growing interest of the scientific community in developing new biological therapies that can both improve shoulder function and promote tendon healing. The aim of the study is to evaluate, through the Constant Murley Score (CMS), the performance of intra-articular treatment with a collagen-based medical device (MD-Shoulder Collagen Medical Device) in recovering joint function and reducing pain in Rotator Cuff Syndrome.

Detailed Description

This is a pilot monocentric Clinical Investigation based on a one sample design. The purpose of this research is to evaluate, through the CMS functional scale, the performance of intra-articular treatment with a collagen-based medical device in recovering joint function and reducing associated pain. The safety of the treatment will also be assessed. Variables will be assessed at 6 different times points: at baseline (day0), after weeks 2, weeks 4, months 3, months 6, and after months 12.

The total duration of the study will be 16 months. There will be a 4-month subject selection and recruitment period and a 12-month treatment and observation period.

A total of 24 subjects with painful shoulder in Rotator Cuff Syndrome will be enrolled. The recruitment phase will be closed no sooner than the number of subjects planned in the study has been reached. Enrollment will involve subjects with rotator cuff syndrome who are eligible according to the selection criteria. Diagnosis will be performed by the Principal Investigator through clinical examination and instrumental investigation with shoulder MRI. The investigators will explain the rationale for the investigation plan and the procedures involved to the eligible subjects. Consent to participate in the study will then be sought. Prior or ongoing the treatments of any kind will be documented.

In order to monitor analgesic consumption (Celecoxib 200mg / Paracetamol 1000 mg) used during the study in case of pain onset, a clinical diary will be given to the subject in which to indicate the day and dose of medication used.

Conditions

Rotator Cuff Tendinitis; Syndrome Rotator Cuff; Tendinopathy; Tendinoses, Rotator Cuff; Rotator Cuff Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MD-Shoulder Medical Device

MD-Shoulder Medical Device type I collagen based

Group Type: EXPERIMENTAL

MD-Shoulder Collagen Medical Device

Intervention Type: DEVICE

Only one experimental group is scheduled by the Investigation Plan to be treated with 2-mL volume ultrasound-guided infiltrations of MD-Shoulder Collagen Medical Device (GUNA, Milan-Italy).

Subjects will be treated with number one ultrasound-guided infiltration at the time of enrollment, 2 weeks after enrollment, and 4 weeks after enrollment.

Intra-articular infiltrations will be performed with 5cc syringes and 22-gauge needles.

MD-Shoulder Collagen Medical Device will be infiltrated within the scapulohumeral joint under conditions of complete asepsis.

Interventions

MD-Shoulder Collagen Medical Device

Only one experimental group is scheduled by the Investigation Plan to be treated with 2-mL volume ultrasound-guided infiltrations of MD-Shoulder Collagen Medical Device (GUNA, Milan-Italy).

Subjects will be treated with number one ultrasound-guided infiltration at the time of enrollment, 2 weeks after enrollment, and 4 weeks after enrollment.

Intra-articular infiltrations will be performed with 5cc syringes and 22-gauge needles.

MD-Shoulder Collagen Medical Device will be infiltrated within the scapulohumeral joint under conditions of complete asepsis.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guna S.p.a

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randelli RP Pietro Simone, Prof

Role: PRINCIPAL_INVESTIGATOR

Gaetano Pini CTO

Locations

Gaetano Pini CTO

Milan, MI, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MDG2021184

Identifier Type: -

Identifier Source: org_study_id