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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Performance and Safety Evaluation of Type I Collagen (MD-Shoulder Collagen Medical Device) in the Treatment of Rotator Cuff Syndrome ''ROPIRAMED PILOT STUDY''

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

Intervention / Treatment
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* Device: MD-Shoulder Collagen Medical Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: one sample study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MD-Shoulder Medical Device<br>MD-Shoulder Medical Device type I collagen based | Device: MD-Shoulder Collagen Medical Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation, using the Constant-Murley Functional Scale (CMS), score ranges from 0 to 100 points, representing worst and best shoulder function respectively. | The primary End Point will consist of evaluating, through the Constant-Murley Score (CMS), the effectiveness, in terms of performance, of MD-Shoulder Collagen Medical Device in recovering joint function and reducing associated pain at months 3, compared with day 0. An increase of at least 13 points on the CMS scale is considered clinically significant. | months 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of MD-Shoulder Collagen Medical Device performance using the Constant-Murley from 0 to 100 points, representing worst and best shoulder function respectively. | Secondary Endpoints will consist of the evaluation of MD-Shoulder Collagen Medical device through CMS at months 6 and months 12 compared to day 0. | months 6, months12 | 
| Evaluation of MD-Shoulder Collagen Medical Device with Numeric Rating Scale the number between 0 and 10, zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'. | Secondary Endpoints will consist of the evaluation of MD-Shoulder Collagen Medical Device, with NRS (Numeric Rating Scale) at weeks 2, weeks 4, months 3, mouth 6, mouth 12 compared to day 0. | 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 | Secondary Endpoints will consist of the evaluation of MD-Shoulder Collagen Medical with American Shoulder and Elbow Surgeons (ASES), Simply Shoulder Test (SST) and Range Of Motion (ROM) at months 3, mouth 6, mouth 12 compared to day 0 | 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. | Secondary Endpoints will consist of the evaluation of MD-Shoulder Collagen Medical Device with simply shoulder test (SST) at months 3, mouth 6, mouth 12 compared to day 0 number of yes/number of completed items 100 = % of yes response. 0 = worst and 100 = best function | months 3, months 6, months12 | 
| Evaluation of MD-Shoulder Collagen Medical Device with range of motion (ROM) with goniometers measure range of motion in degrees, from zero to 180 or 360, and come in various shapes and sizes to be used on particular joints. | Secondary Endpoints will consist of the evaluation of MD-Shoulder Collagen Medical with Range Of Motion (ROM) at months 3, mouth 6, mouth 12 compared to day 0 | months 3, months 6, months12 | 
| 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 Endpoints will consist of the 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. | month 12 | 
| Evaluation of MD-Shoulder Collagen Medical with assessment of analgesic drug unit consumption based on clinical diary at various phases of the study. | Secondary Endpoints will consist of the evaluation of MD-Shoulder Collagen Medical with Analgesic consumption at various phases of the study with use of clinical diary | months 3, months 6, months 12 | 
| Evaluation of Adverse Events. | Evaluation of Adverse Events. | weeks 2, weeks 4, months 3, months 6, months 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Collagen Type I, MD-Shoulder Collagen Medical Device, Constant Murley Score, American Shoulder and Elbow Surgeons, Numeric Rating Scale, Simply Shoulder Test, Range of Motion