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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MD-Shoulder Medical Device | Experimental | MD-Shoulder Medical Device type I collagen based |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of MD-Shoulder Collagen Medical Device Performance Using the Constant-Murley Score | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randelli RP Pietro Simone, Prof | Gaetano Pini CTO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaetano Pini CTO | Milan | MI | 20122 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | MD-Shoulder Medical Device | MD-Shoulder Medical Device type I collagen based 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2022 |
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one sample study
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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). | 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 |
| Safety Evaluation | Evaluation of Adverse Events. | weeks 2, weeks 4, months 3, months 6, months 12 |
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| ID | Title | Description |
|---|---|---|
| BG000 | MD-Shoulder Medical Device | MD-Shoulder Medical Device type I collagen based 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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) | A total of 24 subjects with painful shoulder in rotator cuff tendinopathy have been enrolled. Only subjects were be included:
| Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after baseline (Day 0) |
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| Secondary | Evaluation of MD-Shoulder Collagen Medical Device Performance Using the Constant-Murley Score | 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. | Not Posted | months 6, months12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluation of MD-Shoulder Collagen Medical Device With Numeric Rating Scale | 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. | Not Posted | weeks 2, weeks 4, months 3, months 6, months 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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 | Not Posted | months 3 months 6, months 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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 | Not Posted | months 3, months 6, months12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluation of MD-Shoulder Collagen Medical Device With Range of Motion (ROM). | 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 | Not Posted | months 3, months 6, months12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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. | Not Posted | month 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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 | Not Posted | months 3, months 6, months 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety Evaluation | Evaluation of Adverse Events. | Not Posted | weeks 2, weeks 4, months 3, months 6, months 12 | Participants |
They were followed for 12 months, constantly monitoring any adverse events During the entire investigation period, the Investigators team reported n°1 Adverse Event (AE) at time T0 after the first infiltration. No serious adverse events (SAEs) occurred in the 24 patients in the 12-month study period.
Adverse events were assessed through non-systematic observation over 12 months. All-cause mortality, serious adverse events, and other adverse events were not systematically assessed, as they were not among the pre-specified study endpoints.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MD-Shoulder Medical Device | MD-Shoulder Medical Device type I collagen based 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. | 0 | 24 | 0 | 24 | 1 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local redness following infiltration | General disorders | Non-systematic Assessment | Observed after first injection at time T0. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Miranda (Clinical Research Manager); Kamilia Laarej (TSU&CRA) | Guna S.p.a. | 02 280.18.(358)-(359) | v.miranda@guna.it; k.laarej@guna.it |
| May 20, 2025 |
| Prot_SAP_002.pdf |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D052256 | Tendinopathy |
| C000631847 | Osteogenesis Imperfecta, Type IV |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| Unknown or Not Reported |
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