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N/A N=24 Treatment

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

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

Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline in Constant-Murley Score (CMS) at 3 Months — 10.03 units on a scale — p=0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MD-Shoulder Collagen Medical Device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Guna S.p.a
Primary completion
Jan 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Constant-Murley Score (CMS) at 3 Months
10.03 0.001 sig
SECONDARY
Evaluation of MD-Shoulder Collagen Medical Device Performance Using the Constant-Murley Score
SECONDARY
Evaluation of MD-Shoulder Collagen Medical Device With Numeric Rating Scale
SECONDARY
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
SECONDARY
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.
SECONDARY
Evaluation of MD-Shoulder Collagen Medical Device With Range of Motion (ROM).
SECONDARY
Evaluation of MD-Shoulder Collagen Medical With Cuff Integrity at Mouth 12 Compared to Day 0 by Performing With Magnetic Resonance Imaging (MRI) of the Treated Shoulder.
SECONDARY
Evaluation of MD-Shoulder Collagen Medical With Assessment of Analgesic Drug Unit Consumption Based on Clinical Diary at Various Phases of the Study.
SECONDARY
Safety Evaluation

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05489484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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