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

NCT05489484 | Completed Results

• 1 other identifier: MDG2021184
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Collagen Type I; MD-Shoulder Collagen Medical Device; Shoulder; Constant Murley Score; American Shoulder and Elbow Surgeons; Numeric Rating Scale; Simply Shoulder Test; Range of Motion

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Constant-Murley Score (CMS) at 3 Months

  The primary outcome is the change from baseline in the Constant-Murley Score (CMS) at 3 months after the first intra-articular injection. The CMS is a validated clinical scale ranging from 0 to 100 points, where higher scores indicate better shoulder function and less pain. It includes four subdomains: pain (15 points), activities of daily living (20 points), range of motion (40 points), and strength (25 points). An increase of at least 13 points is considered very clinically significant. Results will be analyzed as the mean change in CMS from baseline (Day 0) to Month 3. Unit of Measure: Points on the Constant-Murley Scale (0-100)

  3 months after baseline (Day 0)

Secondary Outcomes (8)

• Evaluation of MD-Shoulder Collagen Medical Device Performance Using the Constant-Murley Score

  months 6, months12

• Evaluation of MD-Shoulder Collagen Medical Device With Numeric Rating Scale

  weeks 2, weeks 4, months 3, months 6, months 12

• Evaluation of MD-Shoulder Collagen Medical Device With American Shoulder and Elbow Surgeons (ASES)Scores Range From 0 to 100 With a Score of 0 Indicating a Worse Shoulder Condition and 100 Indicating a Better Shoulder Condition

  months 3 months 6, months 12

• Evaluation of MD-Shoulder Collagen Medical Device With Simply Shoulder Test (SST), the Items on the Scale Measure the Ability of the Affected Shoulder to Perform Work Duties, Dressing, Bathing, Lifting, Carrying and Throwing.

  months 3, months 6, months12

• Evaluation of MD-Shoulder Collagen Medical Device With Range of Motion (ROM).

  months 3, months 6, months12

Study Arms (1)

MD-Shoulder Medical Device

EXPERIMENTAL

MD-Shoulder Medical Device type I collagen based

Device: MD-Shoulder Collagen Medical Device

Interventions

MD-Shoulder Collagen Medical Device 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.

MD-Shoulder Medical Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guna S.p.a: lead

Study Sites (1)

Gaetano Pini CTO

Milan, MI, 20122, Italy

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Tendinopathy; Osteogenesis Imperfecta, Type IV

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Muscular Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Vincenzo Miranda (Clinical Research Manager); Kamilia Laarej (TSU&CRA)
• Organization: Guna S.p.a.

v.miranda@guna.it; k.laarej@guna.it

02 280.18.(358)-(359)

Study Officials

• Randelli RP Pietro Simone, Prof

  Gaetano Pini CTO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: one sample study

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: August 5, 2022
• Study Start: July 4, 2022
• Primary Completion: January 17, 2025
• Study Completion: March 29, 2025
• Last Updated: July 17, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)