Trial Outcomes & Findings for Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome (NCT NCT05489484)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

3 months after baseline (Day 0)

Results posted on

2025-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	24
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study withdrawn	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MD-Shoulder Medical Device n=24 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after baseline (Day 0)

Population: A total of 24 subjects with painful shoulder in rotator cuff tendinopathy have been enrolled. Only subjects were be included: * belonging to the U.O.C. 1st Orthopedic Clinic (Gaetano Pini Orthopedic Institute, Milan, Italy); * who meet the inclusion criteria and have no exclusion criteria.

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)

Outcome measures

Outcome measures
Measure	MD-Shoulder Medical Device n=23 Participants 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.
Change From Baseline in Constant-Murley Score (CMS) at 3 Months	10.03 units on a scale Interval 3.63 to 16.0

SECONDARY outcome

Timeframe: months 6, months12

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3 months 6, months 12

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3, months 6, months12

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3, months 6, months12

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: month 12

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3, months 6, months 12

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Evaluation of Adverse Events.

Outcome measures

Outcome data not reported

Adverse Events

MD-Shoulder Medical Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MD-Shoulder Medical Device n=24 participants at risk 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.
General disorders Local redness following infiltration	4.2% 1/24 • Number of events 1 • 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.

Additional Information

Vincenzo Miranda (Clinical Research Manager); Kamilia Laarej (TSU&CRA)

Guna S.p.a.

Phone: 02 280.18.(358)-(359)

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place