Rotator Cuff InjuriesNCT04258605
ASHCOM Shoulder System and Its Related Instruments
An observational study of Rotator Cuff Injuries and Shoulder Pain, run by Zimmer Biomet at 1 site in Italy.
Trial summary
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy; Traumatic
- What is being tested?
- ASHCOM Shoulder System
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2019to 13 Aug 2024
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from severe shoulder pain and disability indicated for implantation of the ASHCOM Shoulder System and who meet all inclusion and none of the exclusion criteria.
Who may be able to join
- Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
- Patient has given written consent to take part in the study by signing the "Patient Consent Form".
- Patient is 18-80 years of age, inclusive.
- Patient is skeletally mature.
- Patient requires a primary, fracture or revision reverse total shoulder replacement for the relief of pain and has significant disability due to gross rotator cuff deficiency.
- Patient's joint is anatomically and structurally suited to receive the selected implants.
- Patient has a functional deltoid muscle.
Who cannot join
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject.
- Patient meets at least one of the contraindications:
- Signs of infection
Show all 10Show fewer
- Significant injury to the upper brachial plexus
- Non-functional deltoid muscle
- Insufficient quality and/or quantity of glenoid or humeral bone
- Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASHCOM Shoulder System and Its Related Instruments - A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
Read the detailed description
This study is a multicenter, prospective, non-controlled Post-Market Clinical Follow-up study involving orthopaedic surgeons skilled in reverse shoulder arthroplasty procedures. A minimum of three study centers will be involved. A total number of 97 implants will be included into the study.
The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
The secondary endpoint is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Assessments of the overall pain, functional performance, survival, quality of life and radiographic parameters of all enrolled study subjects will be evaluated in addition.
- Being tested
- ASHCOM Shoulder System
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASHCOM Shoulder SystemDevice
Reverse Shoulder Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| ASHCOM Shoulder System subjects | Subjects implanted with the ASHCOM Shoulder System Receives: Device: ASHCOM Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of Implant System (Kaplan Meier)
The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method.
Due to early study termination, the survival of the implant was analyzed at 3 years.
Measured: 3 years
Secondary outcomes (5)
The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)
The secondary endpoint of this study is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Due to early study termination, the Constant and Murley Score was assessed at 2 years.
The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).
Measured: Pre-operative (baseline), 1 year, 2 years post-operative
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following total shoulder arthroplasty. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible and a minimum of 0, representing the worst possible.
The outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19.
Measured: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
EQ-5D-5L Score
The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. It included the Health State, which is a self-reported assessment about the patient's health on that day at a VAS from 0 to 100 with 100 being the best health one can imagine and 0 the worst.
Measured: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
Subjective Shoulder Value (SSV)
The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal.
Measured: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
Radiographic Parameters
Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral stem subsidence / glenoid component migration), heterotopic ossification and scapular notching
Measured: 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start10 Dec 2019
- Primary completion18 Dec 2023
- Study completion13 Aug 2024
Why it stopped: Termination of PMCF study due to product discontinuation.
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 InjuriesStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcello Stamilla, MD, Principal investigator, Clinica del Mediterraneo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258605
- Sponsor's protocol ID
- CME2017-67E
- Status last verified
- Dec 2024
- First submitted
- 4 Feb 2020
- Last updated
- 3 Apr 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASHCOM Shoulder System and Its Related Instruments - A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT04258605
- Acronym / sponsor ID
- CME2017-67E
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Termination of PMCF study due to product discontinuation.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
Detailed description
This study is a multicenter, prospective, non-controlled Post-Market Clinical Follow-up study involving orthopaedic surgeons skilled in reverse shoulder arthroplasty procedures. A minimum of three study centers will be involved. A total number of 97 implants will be included into the study.
The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
The secondary endpoint is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Assessments of the overall pain, functional performance, survival, quality of life and radiographic parameters of all enrolled study subjects will be evaluated in addition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASHCOM Shoulder System subjects | – | Device: ASHCOM Shoulder SystemSubjects implanted with the ASHCOM Shoulder System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from severe shoulder pain and disability indicated for implantation of the ASHCOM Shoulder System and who meet all inclusion and none of the exclusion criteria.
Key inclusion criteria (7 listed)
- Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
- Patient has given written consent to take part in the study by signing the "Patient Consent Form".
- Patient is 18-80 years of age, inclusive.
- Patient is skeletally mature.
- Patient requires a primary, fracture or revision reverse total shoulder replacement for the relief of pain and has significant disability due to gross rotator cuff deficiency.
Key exclusion criteria (10 listed)
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject.
- Patient meets at least one of the contraindications:
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 |
|---|---|---|
| ASHCOM Shoulder SystemReverse Shoulder Arthroplasty | Device | ASHCOM Shoulder System subjects |
Primary outcome
Survival of Implant System (Kaplan Meier)
Time frame: 3 years
The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. Due to early study termination, the survival of the implant was analyzed at 3 years.
5 secondary outcomes
The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)
Time frame: Pre-operative (baseline), 1 year, 2 years post-operative
Oxford Shoulder Score (OSS)
Time frame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
EQ-5D-5L Score
Time frame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
Subjective Shoulder Value (SSV)
Time frame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
Radiographic Parameters
Time frame: 2 years post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 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.
Marcello Stamilla, MD principal investigator
Clinica del Mediterraneo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injuries and Shoulder Pain, run by Zimmer Biomet 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 7 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: stopped early, as of the sponsor's last update on 3 Apr 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 3 Apr 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?
Survival of Implant System (Kaplan Meier) (time frame: 3 years). 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 3 Apr 2025.