Rotator Cuff TendinitisROPIRAMEDNCT05489484
Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome
A study testing MD-Shoulder Collagen Medical Device in people with Rotator Cuff Tendinitis and Syndrome Rotator Cuff, run by Guna S.p.a at 1 site in Italy.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tendinitis, Syndrome Rotator Cuff, Tendinopathy
- What is being tested?
- MD-Shoulder Collagen Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jul 2022to 29 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Subjects with coagulopathies.
- Subjects on chronic treatment with immunosuppressants.
- Subjects with an allergy to porcine collagen.
- Subjects in pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance and Safety Evaluation of Type I Collagen (MD-Shoulder Collagen Medical Device) in the Treatment of Rotator Cuff Syndrome ''ROPIRAMED PILOT STUDY''
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.
Read the 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
- Being tested
- MD-Shoulder Collagen Medical Device
- 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
- Medical subject headings
- Rotator Cuff Injuries, Tendinopathy, Osteogenesis Imperfecta, Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-Shoulder Collagen Medical DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MD-Shoulder Medical Device | Experimental | MD-Shoulder Medical Device type I collagen based Receives: Device: MD-Shoulder Collagen Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months after baseline (Day 0)
Secondary outcomes (8)
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.
Measured: months 6, months12
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: months 3, months 6, months 12
Safety Evaluation
Evaluation of Adverse Events.
Measured: weeks 2, weeks 4, months 3, months 6, months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start4 Jul 2022
- Primary completion17 Jan 2025
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one sample study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guna S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randelli RP Pietro Simone, Prof, Principal investigator, Gaetano Pini CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489484
- Sponsor's protocol ID
- MDG2021184
- Acronym
- ROPIRAMED
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2022
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety Evaluation of Type I Collagen (MD-Shoulder Collagen Medical Device) in the Treatment of Rotator Cuff Syndrome ''ROPIRAMED PILOT STUDY''
- ClinicalTrials.gov ID
- NCT05489484
- Acronym / sponsor ID
- ROPIRAMED / MDG2021184
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Guna S.p.aIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Posted 8 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one sample study
| Arm | Type | Receives |
|---|---|---|
| MD-Shoulder Medical Device | Experimental | Device: MD-Shoulder Collagen Medical DeviceMD-Shoulder Medical Device type I collagen based |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD-Shoulder Collagen Medical DeviceOnly 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. | Device | MD-Shoulder Medical Device |
Primary outcome
Change From Baseline in Constant-Murley Score (CMS) at 3 Months
Time frame: 3 months after baseline (Day 0)
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)
8 secondary outcomes
Evaluation of MD-Shoulder Collagen Medical Device Performance Using the Constant-Murley Score
Time frame: months 6, months12
Evaluation of MD-Shoulder Collagen Medical Device With Numeric Rating Scale
Time frame: 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
Time frame: 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.
Time frame: months 3, months 6, months12
Evaluation of MD-Shoulder Collagen Medical Device With Range of Motion (ROM).
Time frame: 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.
Time frame: 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.
Time frame: months 3, months 6, months 12
Safety Evaluation
Time frame: weeks 2, weeks 4, months 3, months 6, months 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randelli RP Pietro Simone, Prof principal investigator
Gaetano Pini CTO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD-Shoulder Collagen Medical Device in people with Rotator Cuff Tendinitis and Syndrome Rotator Cuff, run by Guna S.p.a at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Constant-Murley Score (CMS) at 3 Months (time frame: 3 months after baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.